Search

OBJECTIVE The objective of this six-week, examiner-blind clinical study was to assess the tooth whitening and extrinsic tooth stain removal efficacy of a new dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base (Test Dentifrice), relative to that of commercially available hexametaphosphate-containing whitening dentifrice (Positive Control Dentifrice). METHODOLOGY Following a baseline oral soft tissue examination and scoring of extrinsic tooth stain and tooth shade, qualifying adult male and female subjects from the Harrisburg, Pennsylvania area were randomized into either the Test or Positive Control Dentifrice group. The two groups were balanced for gender, extrinsic tooth stain, and tooth shade scores. All subjects were provided their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for two minutes twice daily (morning and evening) using only the dentifrice provided, and to refrain from using any other oral hygiene products for the entire six weeks of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Oral soft tissue, extrinsic tooth stain, and tooth shade assessments for each subject were repeated after two and six weeks of product use. All statistical tests were two sided and employed a level of significance of alpha = 0.05. RESULTS Fifty-six (56) subjects complied with the protocol and completed the entire study. Compared to baseline at both the two- and six-week examinations, the Test Dentifrice group had statistically significant reductions in extrinsic tooth stain area and intensity, and statistically significant mean shade rank reductions, with a six-week reduction of 4.81. In contrast, at six weeks, the Positive Control dentifrice had a statistically significant increase in tooth stain area, a non-significant increase in tooth stain intensity, and a statistically significant mean 1.40 shade rank score reduction. At both the two- and six-week examinations, the Test Dentifrice group had statistically significantly lighter tooth shades and statistically significantly lower levels of extrinsic tooth stain area and intensity than the Positive Control Dentifrice group. CONCLUSION A new whitening dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base has significant efficacy in tooth whitening and extrinsic stain removal, and provides a statistically significantly greater level of efficacy for both tooth whitening and extrinsic tooth stain removal than the commercially available Positive Control Dentifrice.

This study tests the hypothesis that salivary extracellular RNA (exRNA) biomarkers can be developed for gingivitis detection and monitoring disease regression. MATERIALS AND METHODS: Salivary exRNA biomarker candidates were developed from a total of 100 gingivitis and non-gingivitis individuals using Affymetrix's expression microarrays. The top 10 differentially expressed exRNAs were tested in a clinical cohort to determine whether the discovered salivary exRNA markers for gingivitis were associated with clinical gingivitis and disease regression. For this purpose, unstimulated saliva was collected from 30 randomly selected gingivitis subjects, the gingival and plaque indexes scores were taken at baseline, 3 and 6 weeks and salivary exRNAs were assayed by means of reverse transcription quantitative polymerase chain reaction. RESULTS: Eight salivary exRNA biomarkers developed for gingivitis were statistically significantly changed over time, consistent with disease regression. A panel of four salivary exRNAs [SPRR1A, lnc-TET3-2:1, FAM25A, CRCT1] can detect gingivitis with a clinical performance of 0.91 area under the curve, with 71% sensitivity and 100% specificity. CONCLUSIONS: The clinical values of the developed salivary exRNA biomarkers are associated with gingivitis regression. They offer strong potential to be advanced for definitive validation and clinical laboratory development test. 2016UEM23 4.164 JCR (2018) Q1, 4/91 Dentistry, Oral Surgery & Medicine 2.581 SJR (2018) Q1, 2/12 Periodontics No data IDR 2018 UEM

ObjectiveEvaluate the efficacy of 0.8% arginine, potassium nitrate and sodium fluoride mouthwashes on dentine hypersensitivity reduction.MethodsSix week randomized, double blinded, two cell, parallel single centre clinical study in the Dominican Republic; subjects were randomized into three treatment groups: mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base (arginine); mouthwash containing 2.4% potassium nitrate and 0.022% sodium fluoride (potassium nitrate); a control mouthwash containing 0.05% sodium fluoride (negative control). Tactile and air-blast dentine hypersensitivity assessments were conducted at baseline, thirty minutes post rinsing and two, four, and six weeks of twice-daily product use. For treatment group comparisons, ANCOVA and post hoc Tukey's pair-wise comparisons (α=0.05) were done.ResultsSeventy-five subjects were enrolled; 69 subjects completed the study. There were no differences after thirty minutes of a single use, among the three groups with respect to mean tactile and air blast hypersensitivity scores compared to potassium nitrate and negative control mouthwashes (p

A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone.

Aim: Oral malodor (halitosis) is a widespread condition caused by oral bacteria, particularly sulfur compound-producing species. This study assessed the effect of a triclosan/copolymer-containing dentifrice and a novel toothbrush with attached tongue cleaner on oral malodor and on the bacteria colonizing the dorsal surface of the tongue. Materials and Methods: 14 adult subjects with oral malodor defined as organoleptic scores ≥ 3 (scale 0 - 5) and mouth air sulfur levels ≥ 250 ppb participated in this study. Subjects were examined at baseline and after 28 days use of the triclosan dentifrice and toothbrush/tongue cleaner for: 1) organoleptic assessment; 2) mouth air sulfur levels; 3) tongue coating; and, 4) dorsal tongue surface microorganisms. Total bacterial numbers were assayed by microscopy. Dot-blot hybridization was used to assess a panel of 20 oral bacteria. Results: After 28 days, all subjects had significantly reduced organoleptic scores and mouth air sulfur levels compared to baseline (p 70% reduction in microbial numbers (p Enterococcus faecalis (p Peptostreptococcus micros (p Prevotella melaninogenica (p Porphyromonas gingivalis (p Solobacterium moorei (p

Studies with cetylpyridinium chloride (CPC) mouth rinses that range from 1 use to 6 months of use have documented the clinical efficacy of these formulations on supragingival plaque and gingivitis.The objective of the present study was to compare the effects of a commercially available mouth rinse containing 0.05% CPC versus a fluoride mouth rinse on the anaerobic bacteria found in dental plaque. Antimicrobial effects on the organisms of the supragingival plaque, a natural biofilm, were determined after 1 use and after 14 days of use of each mouth rinse.After enrollment, adult subjects from China completed a 1-week washout period and provided baseline samples of supragingival plaque for analysis of anaerobic bacteria. Subjects were randomly assigned to receive a commercially available mouth rinse formulated with 0.05% CPC or a fluoride mouth rinse. Subjects were assigned to each group according to a computer-generated randomization sequence. They were instructed to rinse with 20 mL of either the CPC or the fluoride mouth rinse for 30 seconds. Microbiologic analyses of dental plaque samples were conducted 12 hours after the first use of assigned mouth rinse. Subjects were instructed to continue twice-daily rinsing with their assigned mouth rinse for the next 14 days in addition to brushing their teeth with a commercial fluoride toothpaste. Dental plaque samples for microbiologic analyses were collected on day 15; this was done 12 hours after the final use of the assigned mouth rinses. A dentist conducted oral examinations before each sample collection to evaluate hard and soft tissue health over the course of the study.The study included 117 adults (62 females, mean age, 28.70 years; 55 males, mean age, 30.41 years). Subjects rinsing with the CPC mouthwash (n = 58; mean age, 29.41 years) reported significant reductions in anaerobic bacteria versus those issued the fluoride rinse (n = 59; mean age, 29.61 years) 12 hours after 1 use and 12 hours after 14 days of use (P0.001). The mean percent reduction in anaerobic bacteria between the CPC mouth rinse and the fluoride mouth rinse was 29.98% after 1 use and 57.90% after 14 days of use. All enrolled subjects completed the study without any adverse events.Use of the CPC mouth rinse was associated with significant reductions in the anaerobic bacteria of supragingival plaque compared with fluoride mouth rinse use in these adult subjects.

The control of oral malodor is well-recognized in efforts to improve oral health. Antimicrobial formulations can mitigate oral malodor, however, procedures to assess effects on oral bacteria including those implicated in halitosis are unavailable. This investigation examined the antimicrobial effects of a new liquid triclosan/copolymer dentifrice (test) formulation that demonstrated significant inhibition of oral malodor in previous organoleptic clinical studies. Procedures compared antimicrobial effects of the test and control formulations on a range of oral micro-organisms including members implicated in halitosis, substantive antimicrobial effects of formulations with hydroxyapatite as a surrogate for human teeth and ex vivo effects on oral bacteria from human volunteers. With Actinomyces viscosus, as a model system, the test formulation demonstrated a dose-dependent effect. At these concentrations the test formulation provided significant antimicrobial effects on 13 strains of oral bacteria including those implicated in bad breath at selected posttreatment time points. Treatment of hydroxyapatite by the test dentifrice resulted in a significant and substantive antimicrobial effect vs. controls. Oral bacteria from subjects treated ex vivo with the test dentifrice resulted in significant reductions in cultivable oral bacteria and odorigenic bacteria producing hydrogen sulfide. In summary, microbiological methods adapted to study odorigenic bacteria demonstrate the significant antimicrobial effects of the test (triclosan/copolymer) dentifrice with laboratory and clinical strains of oral bacteria implicated in bad breath.

Background The authors measured the enamel remineralization of dental inter-proximal surfaces by a triclosan/copolymer/fluoride liquid dentifrice to test its performance against that of a standard toothpaste. Methods In a randomized, crossover, blinded, in situ protocol, the authors fitted 19 healthy adult subjects with mandibular appliances holding bilateral, interproximal bovine enamel slabs. They measured initial abrasion levels and fluoride content. In a two-phase crossover protocol, they evaluated the percentage of surface mineral recovery, or SMR, and fluoride uptake caused by the experimental dentifrice and a fluoride-containing traditional control toothpaste. Results Abrasion depths were similar and not different statistically ( P > .05). The interproximal blocks exposed to the triclosan-containing liquid dentifrice had a mean fluoride uptake that was nearly 100 parts per million (13.1 percent) greater than that achieved with the American Dental Association–accepted control dentifrice. This finding, while not statistically significant, may indicate enhanced performance of the experimental dentifrice because the initial enamel slab abrasion depths were shown to be quite uniform. Moreover, the blocks exposed to the experimental toothpaste had a 49.8 percent SMR, while the positive control blocks had an SMR of only 36.9 percent. This enhanced remineralization performance was statistically significant ( P Conclusions This is the first study to show enhanced performance of a triclosan-containing liquid dentifrice in preventing interproximal dental caries. The difference in percentage of SMR was s statistically significant and is likely to be clinically relevant. Clinical Implication The results of this preliminary study offer evidence supporting clinicians' recommendation of the new liquid dentifrice to patients who are prone to developing interproximal carious lesions.

There are often many misconceptions about direct-to-consumer advertising both among the public and among dental professionals. To understand the way in which advertising claims are supported, it is important to differentiate between sound scientific evidence per se and the process of evidence-based decision making. This paper reviews the use of evidence in preparing and supporting advertising claims and provides an overview of the various guidelines and oversights that help maintain the quality of the scientific evidence used to demonstrate product safety and effectiveness. Direct-to-consumer advertising is an important subject and one about which there are often many misconceptions among the public and among dental professionals. Direct-to-consumer advertising can involve prescription as well as over-the-counter (OTC) products. The focus of this article will be on OTC products, though a good portion of the comments can be applicable to prescription products as well. In addition, it will be applicable to the entire gamut of advertising venues, including TV, magazines and newspapers, billboards, and the patient-oriented pamphlets found in dentists' offices. My perspective, therefore, will be from that of a large consumer products company, since these are the companies that run the vast majority of dental consumer product ads on TV and in print media. The primary themes of this paper are the following: Responsible companies base their product claims on sound studies, conducted in accordance with established, generally accepted guidelines and criteria. In addition to internal regulatory and legal controls, the industry is regulated by governmental agencies and, in some cases, voluntarily participates in programs that evaluate its products and their claims based on established criteria. Because multinational consumer products companies must establish and maintain credibility if they are to be successful in the long term, it is essential that their claims be based on sound evidence. This is especially true given the competitive nature of the consumer products market; if a company fails to base its claims on sound data, there is a strong possibility that a competitor will do the work to demonstrate the inaccuracy of the claims and use the data for comparative advertising and/or advertising challenges. In considering the manner in which advertising is evidence based, it is important to differentiate between sound evidence per se and the process of evidence-based decision making. Evidence-based practice uses an assessment of the available evidence, including the published literature, usually in the form of systematic reviews, to establish or confirm the effectiveness and utility of a given procedure or intervention. The objective is to provide a resource that will enable clinicians to use the "current best evidence" in making decisions affecting patient care. 1 The role of evidence in consumer product advertising is somewhat different; for this purpose, its role is to establish and document the safety and effectiveness of a particular product, rather than to establish or confirm the value of a particular intervention. Usually, the need for the product will have already been established before embarking on a development program because there is no point in producing a product for which there may be little demand. Therefore, for example, industry will conduct studies to provide evidence to establish the effectiveness of a new fluoride dentifrice formulation but will not have a need to conduct systematic reviews

Recent studies suggest that periodontal disease and type 2 diabetes mellitus are bi-directionally associated. Identification of a molecular signature for periodontitis using unbiased metabolic profiling could allow identification of biomarkers to assist in the diagnosis and monitoring of both diabetes and periodontal disease. This cross-sectional study identified plasma and salivary metabolic products associated with periodontitis and/or diabetes in order to discover biomarkers that may differentiate or demonstrate an interaction of these diseases. Saliva and plasma samples were analyzed from 161 diabetic and non-diabetic human subjects with a healthy periodontium, gingivitis and periodontitis. Metabolite profiling was performed using Metabolon's platform technology. A total of 772 metabolites were found in plasma and 475 in saliva. Diabetics had significantly higher levels of glucose and α-hydroxybutyrate, the established markers of diabetes, for all periodontal groups of subjects. Comparison of healthy, gingivitis and periodontitis saliva samples within the non-diabetic group confirmed findings from previous studies that included increased levels of markers of cellular energetic stress, increased purine degradation and glutathione metabolism through increased levels of oxidized glutathione and cysteine-glutathione disulfide, markers of oxidative stress, including increased purine degradation metabolites (e.g. guanosine and inosine), increased amino acid levels suggesting protein degradation, and increased ω-3 (docosapentaenoate) and ω-6 fatty acid (linoleate and arachidonate) signatures. Differences in saliva between diabetic and non-diabetic cohorts showed altered signatures of carbohydrate, lipid and oxidative stress exist in the diabetic samples. Global untargeted metabolic profiling of human saliva in diabetics replicated the metabolite signature of periodontal disease progression in non-diabetic patients and revealed unique metabolic signatures associated with periodontal disease in diabetics. The metabolites identified in this study that discriminated the periodontal groups may be useful for developing diagnostics and therapeutics tailored to the diabetic population.

To investigate whether the long term use of two dentifrices containing arginine, an insoluble calcium compound, and fluoride: (1) 1.5% arginine and 1450 ppm F as sodium monofluorophosphate (NaMFP) in a dicalcium phosphate dihydrate (dical) base, and (2) 8.0% arginine and 1450 ppm F as NaMFP in a calcium carbonate base, results in an increase in oral malodor potentially associated with increased ammonia production from breakdown of arginine, as compared to a commercially available fluoride dentifrice without arginine (1450 ppm F as NaMFP in a dical base), after 6 months of product use.A 6-month clinical study, with 119 subjects, was conducted in Chengdu, China, using a double blind, randomized, parallel, three-treatment design. A panel of four expert judges used a nine-point hedonic scale to evaluate breath odor using a protocol designed in concordance with the ADA Acceptance Program Guidelines for Product Used in the Management of Oral Malodor. After a baseline evaluation, study subjects who scored above the threshold value for unpleasant breath odor were stratified by score and randomized into one of three treatment groups. Subjects were provided with a soft-bristled manual toothbrush (Colgate Classic Clean Toothbrush) and brushed their teeth thoroughly in their regular and customary manner for 1 minute with their assigned dentifrice, twice daily. Before breath-odor evaluations, the subjects refrained from eating odorigenic foods and did not use dental hygiene procedures, breath mints, or mouth rinses for 48 hours and 12 hours, respectively.There was no statistically significant difference in oral malodor levels among subjects using the three dentifrices after 1, 3 and 6 months of product use.

Objectives: In two clinical trials of 8 weeks duration, the ability of a new dentifrice, containing potassium nitrate, stannous fluoride and sodium fluoride to reduce dentine hypersensitivity was compared with either a non-desensitising fluoride dentifrice or a commercially available desensitising dentifrice (Sensodyne F) to reduce dentine hypersensitivity. Method: In both studies, the participants had to have at least two sensitive root surfaces. Subjects were stratified by baseline tactile and air blast sensitivity scores and the number of sensitive teeth and randomly allocated to 2 balanced groups. In the first study (N=81) the new dentifrice was compared with a fluoride dentifrice and in the second study (N=105) with Sensodyne F. Participants were requested to brush with their assigned dentifrice twice a day for one minute. At 4 and 8 weeks the sensitive teeth were again examined and their tactile and air blast sensitivity scores recorded. Results: In study 1, the group using the new dentifrice tolerated greater pressure after 4 (34.9 g) and 8 weeks (38.4 g) than the group using the fluoride dentifrice (22.9 g and 19.0 g, respectively). These differences were statistically significant (p

A total of 325 subjects were entered into a double-blind, stratified 2-treatment clinical study that examined the effects of a dentifrice containing 0.3% triclosan, 2% Gantrez copolymer and 0.243% sodium fluoride on supragingival dental plaque and gingivitis. A subset of 159 subjects including 72 men and 87 women participated in the microbiological component of this study, which was designed to detect shifts in supragingival bacterial species in response to triclosan. Subjects were divided into two groups: one performed normal oral hygiene with the triclosan/copolymer dentifrice and a control group used a placebo dentifrice without triclosan. At baseline, 3 and 6 months during treatment and at 6, 12, 18 and 24 weeks post-treatment, supragingival dental plaque was collected from the buccal and lingual surfaces of the 4 first molar teeth and assayed for: 1) bacterial morphotypes by phase-contrast microscopy; 2) select bacterial groups and bacterial species by culture; and 3) target periodontal pathogens including Actinobacillus actinomycetemcomitans, Bacteroides forsythus, Porphyromonas gingivalis and Prevotella intermedia by immunofluorescence microscopy. There were few statistically significant differences between treatment groups in any of the 90 microbiological parameters measured at the 7 different time points. The control group demonstrated significantly higher levels of cultivable Neisseria and higher proportions at the 3-month treatment period of P. gingivalis-infected subjects and mean cells. After 6 months of treatment, the triclosan group demonstrated higher levels of fusiforms. Analysis of triclosan resistance data failed to detect a shift towards increased proportions of bacteria resistant to triclosan, and both treatment groups demonstrated triclosan-resistant strains, predominantly Veillonella dispar. This study confirms the microbiological safety of triclosan-containing dentifrices and suggests that continued use can be associated with beneficial alterations in the bacterial composition of supragingival dental plaque.

Dentin hypersensitivity is a significant clinical problem that affects numerous individuals. This sharp pain, arising from exposed dentin in response to external stimuli, can be a particularly uncomfortable and unpleasant sensation for patients, because it interferes with their quality of life. The objective of this 24-week, single-center, parallel group, double-blind, stratified and randomized clinical study was to evaluate the clinical efficacy of a single professional treatment with an in-office desensitizing paste followed by twice daily brushing with a desensitizing toothpaste and toothbrush for 24 weeks.100 adults with confirmed dentin hypersensitivity were randomly assigned into two groups. One group received a single in-office treatment with a desensitizing paste containing 8% arginine and calcium carbonate (marketed as Colgate Sensitive Pro-Relief Desensitizing Paste and Elmex Sensitive Professional desensitizing paste), after dental scaling, followed by 24 weeks of brushing twice daily with a desensitizing toothpaste containing 8% arginine, calcium carbonate with 1450 ppm fluoride as MFP (marketed as Colgate Sensitive Pro-Relief toothpaste and Elmex Sensitive Professional toothpaste) and using the Colgate Sensitive Pro-Relief toothbrush (Test Group). The other group received a single in-office treatment with Nupro-M pumice prophylaxis paste, after dental scaling, followed by 24 weeks of brushing twice daily with a non-desensitizing toothpaste containing 1450 ppm fluoride as MFP and with the Oral-B Indicator toothbrush (Negative Control Group). Hypersensitivity was reexamined immediately after in-office product application and after 8 and 24 weeks of twice daily brushing.Immediately after professional product application, and after 8 and 24 weeks, subjects assigned to the Test Group demonstrated statistically significant improvements in dentin hypersensitivity compared to subjects assigned to the Negative Control Group in tactile (49.8%, 57.5% and 32.9%, respectively) and air blast (26.0%, 38.4% and 34.3%, respectively) sensitivity scores. The instant reductions in dentin hypersensitivity provided by the single professional application of a desensitizing paste for in-office use, containing 8% arginine and calcium carbonate were maintained by twice daily brushing with the 8% arginine, calcium carbonate toothpaste with 1450 ppm fluoride as MFP and the Colgate Sensitive Pro-Relief toothbrush for at least 24 weeks.

To investigate whether the long-term use (6 months) of an arginine-calcium carbonate-MFP toothpaste would affect calculus formation and/or gingivitis when compared to a calcium carbonate-MFP toothpaste.This was a double-blind clinical study. Eligible adult subjects (120) entered a 2-month pre-test phase of the study. After receiving an evaluation of oral tissue and a dental prophylaxis, the subjects were provided with a regular fluoride toothpaste, a soft-bristled adult toothbrush with instructions to brush their teeth for 1-minute twice daily (morning and evening) for 2 months. The subjects were then examined for baseline calculus using the Volpe-Manhold Calculus Index (VMI) and gingivitis using the Löe-Silness Gingival Index (GI), along with an oral tissue examination. Qualifying subjects were randomized to two treatment groups: (1) Colgate Sensitive Pro-Relief toothpaste containing 8.0% arginine, 1450 ppm MFP and calcium carbonate (Test group), or (2) Colgate Cavity Protection toothpaste containing 1450 ppm MFP and calcium carbonate (Control group). Subjects were stratified by the VMI score and gender. After a dental prophylaxis (VMI=0), the subjects entered a 6-month test phase. Each received the assigned toothpaste and a soft-bristled adult toothbrush for home use with instructions of brushing teeth for 1 minute twice daily (morning and evening). The examinations of VMI, Löe-Silness GI and oral tissues were conducted after 3 and 6 months. Prior to each study visit, subjects refrained from brushing their teeth as well as eating and drinking for 4 hours.99 subjects complied with the study protocol and completed the 6-month test phase. No within-treatment comparison was performed for the VMI because it was brought down to zero after the prophylaxis at the baseline of the test phase. For the Löe-Silness GI, subjects of the Test group exhibited a significant difference from baseline at the 3- and 6-month examinations. The 3-month Löe-Silness GI of the Control group was significantly different from that of the baseline; however, its 6-month Löe-Silness GI was not statistically significantly different from the baseline values. After 3 and 6 months, there were no significant differences between the Test and Control groups with respect to the mean VMI scores; there were no statistically significant differences between the two groups with respect to the Löe-Silness GI results after 3 and 6 months of product use.

The objective of the study was to compare the clinical efficacy in reducing dentin hypersensitivity of a test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (NaF) in a silica base, to a positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as sodium monofluorophosphate (MFP) in a calcium carbonate base, and a negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base.Subjects identified with two hypersensitive teeth using the tactile (Yeaple Probe) and air blast (Schiff's Scale) hypersensitivity methods were assigned to their treatment group. There were 50 subjects per group. Subjects then self-applied the assigned toothpaste to their hypersensitive teeth using a fingertip, then brushed their teeth at home using the same toothpaste twice daily for seven days. Dentin hypersensitivity and oral tissues were evaluated at baseline, immediately after the single application, and after seven days. A chi-square analysis was conducted to examine the effects with respect to gender between treatments. Comparisons of the age and baseline hypersensitivity data among groups were performed using the analysis of variance (ANOVA). Within-treatment effects were analyzed using the paired t-test, while the analysis of covariance (ANCOVA) was used to determine the between-treatment effects. The post hoc Tukey's test was performed for the pair-wise comparisons using a significance level of alpha = 0.05.All 150 subjects complied with the protocol and completed the study. The positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as MFP in a calcium carbonate base provided statistically significant improvements in mean tactile and air blast dentin hypersensitivity scores compared to the negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base (p0.05). The toothpaste containing 8.0% arginine and 1450 ppm fluoride as MFP in a calcium carbonate base (positive control) also provided statistically significant improvements in mean tactile and air blast dentin hypersensitivity scores compared to the test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as NaF in a silica base. The test toothpaste and the negative control toothpaste were not significantly different from each other.The test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as NaF in a silica base, when used for a single topical application and twice-daily brushing for seven days, does not provide statistically significant relief of dentin hypersensitivity compared to a negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base. In contrast, the positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as MFP in a calcium carbonate base provided significantly reduced dentin hypersensitivity compared to the negative control toothpaste, and was significantly more effective than the test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as NaF in a silica base.

The objective of this eight-week, single-center, three-cell, double-blind, and randomized clinical study was to evaluate the dentin hypersensitivity reduction efficacy of three commercially available toothpastes: 1) Colgate Sensitive Pro-Relief Toothpaste (also marketed as elmex Sensitive Professional); 2) Sensodyne Rapid Relief Toothpaste; and (3) Crest Cavity Protection Toothpaste.150 subjects, having two teeth with tactile and air blast hypersensitivity, were assigned to one of the three study groups (50/group). Subjects were then asked to brush their teeth for one minute, twice daily, with the given toothpaste. The dentin hypersensitivity and oral tissues were evaluated at baseline, two weeks, four weeks, and eight weeks. Comparison of the treatment groups with respect to gender was conducted using a chi-square analysis, and with respect to age and baseline hypersensitivity scores was performed using the analysis of variance (ANOVA). Within-treatment effects were analyzed using the paired t-test, while the analysis of covariance (ANCOVA) was used to examine between-treatment effects. The post hoc Tukey test was performed for pair-wise comparisons. All statistical tests were two-sided using a significance level of alpha = 0.05.After two, four, and eight weeks of daily use of the products, all three groups showed a statistically significant reduction from baseline in tactile and air blast dentin hypersensitivity (p0.05). Colgate Sensitive Pro-Relief toothpaste produced a significant improvement in mean tactile and air blast dentin hypersensitivity scores, and was more effective than Sensodyne Rapid Relief toothpaste and Crest Cavity Protection toothpastes (p0.05).Colgate Sensitive Pro-ReliefToothpaste, used twice daily, significantly reduces dentin hypersensitivity, and is significantly more effective in reducing dentin hypersensitivity than Sensodyne Rapid Relief Toothpaste and Crest Cavity Protection Toothpaste.

The purpose of this clinical study was to evaluate the efficacy in reducing dental plaque regrowth of two mouthwashes containing 0.075% cetylpyridinium chloride (CPC), one with 6% alcohol and one alcohol-free, as compared to a negative control mouthwash without CPC, using the Modified Gingival Margin Plaque Index (MGMPI).The study was a double-blind, randomized, three-way crossover, controlled design. Following a washout period, subjects reported to the dental clinic where they were instructed to brush their teeth, used their assigned mouthwash, and were scored by the examining dentist for plaque using the MGMPI method. Subjects were instructed to refrain from all oral hygiene for the next 24 hours, except for rinsing with their assigned mouthwash 12 hours post-brushing. After this 24-hour period, subjects returned to the dental clinic and were once again scored for plaque. This sequence of washout followed by mouthwash use and plaque scoring was repeated until each subject had used all three mouthwashes. An ANOVA was conducted to assess between-group differences.The two test mouthwashes significantly reduced plaque regrowth over a 24-hour period (p0.05) as compared to the negative control mouthwash. The difference between the CPC-containing mouthwashes was not significant (p = 0.4868).Two mouthwashes containing 0.075% CPC, one with 6% alcohol and the other alcohol-free, were found to be safe and effective in reducing plaque accumulation when compared a negative control mouthwash without CPC. In short-term studies, the MGMPI appears useful for evaluating the antiplaque efficacy of mouthwash products.

This single-center, double-blind, randomized, parallel-group clinical study was designed to investigate the extrinsic stain removal efficacy of a new antisensitivity dentifrice containing 0.3% triclosan, 2% polyvinylmethyl ether/maleic acid copolymer (PVM/MA copolymer), 0.243% NaF and a new silica specially-designed to occlude dentin tubules, relative to a Positive Control dentifrice and a Negative Control dentifrice.117 qualifying adults were stratified by baseline Lobene Stain Index scores and randomly assigned to brush twice daily using a soft-bristled toothbrush and one of three dentifrices: (1) the Test Dentifrice; (2) a previously clinically proven dentifrice variant containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF in a high cleaning silica base (Positive Control); and (3) a dentifrice containing 0.243% NaF in a silica base (Negative Control). Extrinsic stain area and stain intensity examinations were repeated after 3 and 6 weeks of product use.Relative to the Negative Control group, the Test group and the Positive Control group exhibited statistically significant improvements in mean Lobene composite stain scores after 3 weeks of product use (39.8% and 40.7% respectively) and after 6 weeks of product use (58.8% and 61.8% respectively). There were no statistically significant differences observed between the stain removal performance of the Test Dentifrice and the Positive Control Dentifrice after 3 and 6 weeks of product use.

To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis.Qualifying adult male and female subjects from the West Palm Beach, Florida area were randomly assigned into one of two treatment groups: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica (Test Dentifrice); and (2) a dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). All subjects received an oral soft and hard tissue examination, baseline plaque and gingivitis were assessed, and subjects were dispensed their assigned dentifrice product along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for plaque and gingivitis, and oral soft and hard tissue assessments were repeated after 3 and 6 months of product use.115 subjects complied with the protocol, and completed the 6-month examination. After 6 months of product use, subjects assigned to the Test Dentifrice group exhibited statistically significant reductions from baseline with respect to Plaque Index, Plaque Severity Index, Gingival Index, and Gingivitis Severity Index scores; and subjects assigned to the Negative Control Dentifrice group exhibited statistically significant reductions from baseline with respect to Gingival Index scores only. Relative to the Negative Control Dentifrice group, the Test Dentifrice group exhibited an 18.8% reduction in Plaque Index; a 50% reduction in Plaque Severity Index; a 19.6% reduction in Gingival Index; and a 60% reduction in Gingivitis Severity Index after 6 months, all of which were statistically significant.

To evaluate the 8-week dentin hypersensitivity efficacy of three toothpastes: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride and specially-designed silica (Test Dentifrice 1); (2) a commercially-available dentifrice containing 0.454% stannous fluoride in a silica base with sodium hexametaphosphate and zinc lactate (Test Dentifrice 2); and (3) a commercially-available non-sensitive dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice).For this 8-week randomized controlled clinical study, qualifying subjects had to have at least two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force, and air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). Subjects brushed twice daily for 1 minute, using the assigned toothpaste and toothbrush. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at the baseline examination and after 4 and 8 weeks of brushing.118 subjects complied with the protocol, and completed the 8-week study. At baseline, the mean tactile sensitivity scores for toothpastes (1), (2) and (3) were 13.6, 14.1 and 13.1; at 4 weeks 28.75, 20.13, and 20.00; and after 8 weeks 33.1, 24.0 and 20.5, respectively. The mean air blast scores for toothpastes (1), (2), and (3) at baseline were 2.5, 2.5, and 2.4; at 4 weeks 1.25, 1.50 and 1.85; and after 8 weeks 0.99, 1.36 and 1.5, respectively. At all time points after the baseline examination, for both tactile and air blast sensitivity scores, the differences between Test Dentifrice 1 and the Negative Control Dentifrice were statistically significant (P0.05). The differences between Test Dentifrice 1 and Test Dentifrice 2 were statistically significant (P0.05) at 4 and 8 weeks after baseline examination for tactile sensitivity scores and at 8 weeks after baseline examination for air blast sensitivity scores.

144 subjects completed a 6-month, double-blind study which examined the effects of a 0.3% triclosan/2% copolymer/0.243% sodium fluoride dentifrice on the microflora of supragingival dental plaque. The subjects were randomly assigned to use, in an oral hygiene program, either the triclosan/copolymer/fluoride test dentifrice or a control dentifrice. The latter had the same formulation as the test dentifrice except it did not contain triclosan. Supragingival plaque was collected from the buccal and lingual surfaces of 4 teeth at baseline, 3 months, and 6 months, and microbiological examined by darkfield microscopy, gram stain morphology', immunofluorescence, and selective and non-selective media. Antimicrobial susceptibilities were determined by agar dilution and whole plaque susceptibility methodologies on plaque samples from 136 subjects at each of the above sample periods and at 6-week intervals for an additional 6 months post-therapy. Both dentifrices resulted in highly statistically significant reductions in the total cultivable flora obtained at both the 3 and 6-month samples relative to baseline as well as at 6 months relative to the 3-month sample. The relative decrease in total anaerobic counts and in strict anaerobes, while not statistically significant, was more pronounced at both the 3- and 6-month sample periods in subjects receiving the triclosan dentifrice than for the controls. Neither dentifrice resulted in detrimental shifts in the microbial composition of the normal flora nor led to the emergence of periodontal or opportunistic pathogens. There was no difference in the relative proportions of the microflora resistance to triclosan or in the number of subjects harboring triclosan-resistant micro-organisms regardless of whether the subjects received the triclosan dentifrice or the control. The proportion of the cultivable flora resistant to triclosan was higher at baseline than at any other sample period. This study demonstrates that the extended use of the 03% triclosan/2% copolymer/fluoride dentifrice does not disrupt the normal microflora associated with supragingival plaque, favor the growth or colonization of periodontal or opportunistic pathogens, or promote the acquisition of microbial resistance.

Periodontitis is a chronic inflammatory disease characterized by tissue destruction. In the diseased oral environment, saliva has primarily been considered to act as a protectant by lubricating the tissue, mineralizing the bones, neutralizing the pH, and combating microbes. To understand the metabolic role that saliva plays in the diseased state, we performed untargeted metabolomic profiling of saliva from healthy and periodontitic individuals. Several classes of biochemicals, including dipeptide, amino acid, carbohydrate, lipids, and nucleotide metabolites, were altered, consistent with increased macromolecular degradation of proteins, triacylglycerol, glycerolphospholipids, polysaccharides, and polynucleotides in the individuals with periodontal disease. These changes partially reflected the enhanced host-bacterial interactions in the diseased state as supported by increased levels of bacterially modified amino acids and creatine metabolite. More importantly, the increased lipase, protease, and glycosidase activities associated with periodontitis generated a more favorable energy environment for oral bacteria, potentially exacerbating the disease state.

To study the effectiveness of a dentifrice containing polyvinylmethyl ether-maleic acid (PVM/MA) copolymer in occluding dentin tubules and investigate the interaction between PVM/MA and type I collagen using surface plasmon resonance (SPR).Fifteen volunteers brushed dentin discs in situ using dentifrices with and without PVM/MA copolymer in a cross-over design. Dentin tubule occlusion was evaluated after brushing, after overnight saliva challenge in vivo for 12 h and after drinking 250 ml of orange juice. Dentin tubule occlusion and tubule size were compared between the two groups using repeated ANOVA and before and after erosive challenges using paired t tests. SPR using type I collagen as ligand and PVM/MA as analyte was performed to evaluate the binding of the two macromolecules.A median of 91% of dentin tubules were occluded after a single brushing in the PVM/MA group, as compared to 9% in the controls. After overnight saliva challenge and 10 min of erosion by orange juice, a median of 73% of the dentin tubules remained fully occluded in the PVM/MA group as compared to zero in the controls. Dentin tubule size increased after orange juice erosion in the controls but not in the PVM/MA group. SPR study showed that PVM/MA bound readily to collagen molecules in a 4 to 1 ratio.Dentifrice containing PVM/MA could effectively occlude dentin tubules and prevent dentin erosion. PVM/MA may improve adhesive retention of intra-tubular dentifrice plugs through binding to dentin surface collagen.Brushing with dentifrice containing adhesive polymers has preventive effect against dentin erosion and dentin sensitivity.

Dental implants and peri-implant tissue are susceptible to disease conditions that may lead to implant loss. The objective of the present study was to describe teeth and implant surroundings as well as clinical health indices and oral microbiologic parameters.A group of 83 adults (42 men and 41 women) were enrolled in the study. Clinical assessments of dental implants and contralateral natural teeth included dental plaque, gingival inflammation, and bleeding on probing. Microbiologic assessments included bacterial culture, light and phase contrast microscopy, and DNA probe hybridization for a panel of 14 target microorganisms. Clinical and microbiologic data were compared by paired t test and ANOVA. P.05 was considered statistically significant.The Plaque Index for the implants was 1.85 ± 0.47, whereas the score for natural teeth was significantly higher, 2.15 ± 0.52. Compared to the samples obtained from the dental implants, the samples from natural teeth demonstrated significantly higher total bacterial cell numbers (P.05). Consistent with the clinical measures of dental plaque, significantly higher numbers of oral bacteria, including aerobic and anaerobic bacteria, were found in dental plaque samples from teeth (aerobic 5.648 ± 0.512, anaerobic 6.243 ± 0.535, P.0001) compared to implants (aerobic 5.430 ± 0.541, anaerobic 5.917 ± 0.523, P.0001). In addition, there were significantly higher numbers of anaerobic (6.243 ± 0.535 and 5.917 ± 0.523, P.0001) than aerobic (5.648 ± 0.512 and 5.430 ± 0.541, P.008) bacteria for samples from teeth and implants, respectively.Clinical and microbiologic analyses provide consistent findings that suggest differences in quantity of plaque and bacterial species between teeth and dental implants. For long-term treatment success, the importance of plaque control and oral hygiene of both periodontal and dental implant therapy is emphasized.

To evaluate the extrinsic stain removal efficacy of a new Pro-Argin formula whitening dentifrice containing 8.0% arginine, a high cleaning calcium carbonate and 1450 ppm fluoride, as monofluorophosphate, after brushing twice daily for 4 and 8 weeks.At the baseline visit, 92 adult subjects were stratified based on their Lobene Stain Index scores and randomized into two treatment groups; one using the new Pro-Argin formula whitening dentifrice (test group) and the other using the original Pro-Argin formula dentifrice (control group). Subjects were instructed to brush twice daily for the duration of the study. Tooth stain evaluations were conducted as stain area and stain intensity according to the Lobene Stain Index.All 92 enrolled subjects complied with the protocol and completed the 8-week study. Baseline scores demonstrated no significant differences between the two treatment groups for the evaluated area and intensity parameters of stain (P0.05). At both the 4- and 8-week post-use evaluations, subjects brushing with the test dentifrice demonstrated significant reductions for all stain parameters versus the control (P0.05). Relative to the control group, the test group demonstrated reductions in mean stain intensity scores of 9.7% and 17.9% at the 4- and 8-week evaluations, respectively. Corresponding reductions in mean stain area scores for the test group relative to the control were 11.7% and 20.8% at the 4- and 8-week evaluations, respectively. (Am JDent 2010;23 Sp Is A:36A-40A).

To compare, with a double-blind, randomized, parallel-design clinical study, the hypersensitivity efficacy of a new Pro-Argin formula dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride to a previously validated Pro-Argin formula dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride, and to a control toothpaste containing calcium carbonate and 1450 ppm fluoride, instantly after a single direct topical self-application using a fingertip, and after subsequent brushing for 3 days.Qualifying subjects from the Chengdu, China area who presented two hypersensitive teeth with a tactile score of 10 to 50 grams, and an air blast score of 2 or 3, participated in this study. The first phase of the study consisted of a single topical application of the assigned product directly onto the hypersensitive surface of each of the two hypersensitive teeth. Study subjects applied a pea-size amount of their toothpaste onto the hypersensitive surface and massaged for 1 minute. The second phase of the study consisted of twice-daily at-home brushing with the toothpaste for 3 days.All one hundred and twenty-two (122) subjects complied with the study protocol and completed the study. There was good balance among the three groups at baseline. The mean tactile sensitivity scores for the new Pro-Argin formula dentifrice, the previously validated Pro-Argin formula dentifrice, and the control dentifrice were at baseline 14.88, 14.76 and 14.38, and after direct application were 28.90, 29.02 and 15.88, and after 3 days of brushing were 34.51, 33.41 and 16.00, respectively. The mean air blast scores at baseline were 2.11, 2.12 and 2.15, and after direct application were 1.21, 1.18 and 2.06, and after 3 days of brushing were 0.80, 0.83 and 1.93, respectively. Immediately after direct application and after 3 days of brushing, for both the tactile and air blast sensitivity scores, the differences between the two dentifrices containing 8.0% arginine and the control were statistically significant. There were no statistically significant differences between the two 8.0% arginine dentifrices immediately after direct application and after 3 days of brushing.

To present the results of an 8-week dentin hypersensitivity clinical study in which the efficacy of a new Pro-Argin formula toothpaste, with gentle whitening benefits, containing 8.0% arginine, a high cleaning calcium carbonate system, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a commercial Pro-Argin formula toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as MFP and a negative control toothpaste containing calcium carbonate and 1450 ppm fluoride as MFP.An 8-week clinical study, with 121 subjects, was conducted in Chengdu, Sichuan, China, using a double-blind, stratified, three-treatment design. Tactile and air blast sensitivity assessments were used to compare the efficacy of the three products.This clinical study demonstrated that the new Pro-Argin formula toothpaste provided a significant reduction in dentin hypersensitivity when used over a period of 8 weeks. The study also showed that the new toothpaste provided significantly greater reductions (P0.05) in dentin hypersensitivity in response to tactile (64.4%, 71.1%, and 61.0%) and air blast (40.7%, 58.8%, and 74.4%) stimuli than the negative control toothpaste containing 1450 ppm fluoride after 2, 4, and 8 weeks of product use, respectively. The results for the new toothpaste did not differ significantly from those of the positive control toothpaste at all time points in the study.

The objective of these three clinical trials was to compare the impact of two commercial products, Colgate Total and Crest Pro-Health, on the formation of dental plaque over a 24-hour period of time. The studies utilized the Modified Gingival Margin Plaque Index (MGMPI), a validated and reliable clinical method for assessing the efficacy of products in reducing plaque build-up.Colgate Total and Crest Pro-Health were the test products for all three clinical trials. Colgate Great Regular Flavor (CR) was used as the universal washout product. Colgate Total, as the only toothpaste approved by the FDA under an NDA for antiplaque, antigingivitis, and anticaries benefits, contains 0.3% triclosan/2.0% PVM/MA copolymer for antigingivitis and antiplaque, as well as 0.243% sodium fluoride (NaF) for anticaries. Crest Pro-Health contains 0.454% stannous fluoride (SnF2) as both a monographed anticaries agent and a monographed antigingivitis agent, along with sodium hexametaphosphate and zinc lactate. Twenty-five healthy subjects meeting all study criteria were included into each of the double-blind studies. Product assignment was randomized and a crossover design was implemented. Informed consent was obtained from all subjects prior to commencement of each of the studies. The studies followed published MGMPI procedures, which require subjects to receive a dental scaling/prophylaxis followed by a one-week washout period prior to use of test products. A baseline MGMPI score was calculated following use of the test products in the dental clinic. Subjects refrained from all oral hygiene for 24 hours following use of each test product, and returned to the clinic for a 24-hour MGMPI score. Following a washout period, subjects repeated the procedure with the other test product as per the crossover design. The differences (delta) between baseline plaque scores and 24-hour plaque scores were independently calculated for each study, and the delta values were compared for the two test products in each of the studies.In all three clinical trials, Colgate Total significantly reduced plaque regrowth over a 24-hour time period (por = 0.05) compared to Crest Pro-Health. Existing differences were determined via a paired t-test, which confirmed that Colgate Total was statistically significantly different from Crest Pro-Health.These in vivo data support the antiplaque benefit of the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice. Additionally, the results support that Colgate Total provides superior efficacy in inhibiting the formation of dental plaque compared to Crest Pro-Health.

To assess the efficacy ofa dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride for controlling established gingivitis and supragingival plaque relative to that of a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a dentifrice containing 0.243% sodium fluoride as a negative control.Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Piscataway, NJ, USA area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for gingivitis and supragingival plaque were repeated after six weeks of product use.One-hundred and seventy-one (171) subjects complied with the protocol and completed the study. Relative to the group using the dentifrice with 0.243% sodium fluoride alone, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride group exhibited statistically significant reductions in gingival index and supragingival plaque index scores of 25.3% and 33.0%, respectively, after six weeks of product use. Similarly, relative to the group using the 0.243% sodium fluoride dentifrice, the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 8.1% and 14.1% after six weeks of product use. Further, relative to the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 18.7% and 22%, respectively.The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque as compared to a regular fluoride dentifrice, and that it provides a greater level of efficacy for the control of gingivitis and supragingival plaque than does a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.

The microbiological effects of biocidal products used for the enhancement of oral hygiene relate to the active compound(s) as well as other formulation components. Here, we test the specificities of selected actives in the absence of multiple excipients. Salivary ecosystems were maintained in tissue culture plate-based hydroxyapatite disc models (HDMs) and modified drip-flow biofilm reactors (MDFRs). Test compounds stannous fluoride (SF), SDS, triclosan (TCS), zinc lactate (ZL) and ZL with SF in combination (ZLSF) were delivered to the HDMs once and four times daily for 6 days to MDFRs. Plaques were characterized by differential viable counting and PCR–denaturing gradient gel electrophoresis (DGGE). TCS and SDS were the most effective compounds against HDM plaques, significantly reducing total viable counts (PPPP

To study the effectiveness of a dentifrice containing polymethyl vinyl ether-maleic acid (PVM/MA) copolymer in a silica base in occluding dentin tubules for treatment of dentin sensitivity.Thirty-two human dentin discs were divided into two groups and brushed in the morning for 30s each to study the dentifrices with and without PVM/MA copolymer. Dentin tubule occlusion and dentin permeability were evaluated with a focus variation three dimensional vertical scanning microscope (IFM) and electrochemical impedance spectroscopy (EIS). After second brushing for 30s in the afternoon the dentin discs were immersed in saliva for 16 h and then subjected to erosion using orange juice for 10 min. The effects of saliva and orange juice on tubule occlusion used in the study of dentifrices were further evaluated with IFM.On average 97.7% of the dentin tubules were occluded after brushing in the PVM/MA group, as compared to 13.3% in the control group (p0.0001). EIS showed that the impedance of the dentin disc increased after treatment with PVM/MA but not in the control group (p0.05). After 16 h of storage in saliva and 10 min of erosion by orange juice, 86% of the dentin tubules remained occluded in the PVM/MA treated dentifrice. The sizes of the tubule openings were increased after orange juice erosion in the control group but not in the PVM/MA group.Dentifrice containing PVM/MA copolymer in a silica base effectively occluded dentin tubules. The intra-tubular plugs were resistant to saliva and orange juice challenges.

Periodontal disease has been studied primarily from clinical outcomes in lengthy human studies. Comprehensive biochemical profiling (metabolomics) has become a powerful tool for disease characterization and biomarker discovery. In a previous study, we performed a metabolomic analysis of gingival crevicular fluid collected from healthy, gingivitis, and periodontitis sites. Many metabolites associated with inflammation, oxidative stress, tissue degradation, and bacterial metabolism were found to be significantly induced by the diseases.A panel of 10 markers was selected from the previous metabolomic study based on their statistical significance. Thirty-nine chronic periodontitis subjects were randomly assigned to a toothpaste regimen: control dentifrice (n = 21) or triclosan-containing dentifrice ([CT] n = 18). Subjects were instructed to use their assigned dentifrice twice daily for 6 weeks. Gingival crevicular fluid samples from six healthy, six gingivitis, and three periodontitis sites were collected from each subject at baseline, 1 week, and 6 weeks. The relative levels of the markers in the samples were determined by mass spectrometry. One-sided matched-paired t tests were performed to compare data from healthy, gingivitis, and periodontitis sites.Statistical analysis indicates that CT significantly decreased the levels of inosine, lysine, putrescine, and xanthine at the gingivitis sites as early as week 1. In contrast, control dentifrice had little effect.This result provides biochemical confirmation for the therapeutic effects of CT on gingivitis. Biomarkers were significantly altered by CT before clinical changes were observed, suggesting that the markers have predicative value for disease state assessment.

To investigate prevalence and severity of gingivitis in representative American adults.Subjects (1,000) in Loma Linda, California; Seattle, Washington; and Boston, Massachusetts were examined for Löe-Silness Gingivitis Index (GI). Mann-Whitney rank sum test was used to determine significances in the GI between genders. The data among study sites and races were compared using the Kruskal-Wallis one-way ANOVA on ranks. The correlation of the GI and age was examined by the Spearman rank order correlation. Age differences among three sites were analyzed using the one-way ANOVA.The race composition of the subjects (mean age 37.9) approximated to the 2004 U.S. Census data. The overall average GI was 1.055. Only 6.1% of subjects showed mean GI0.50; most (93.9%) wereor = 0.50, with 55.7%or = 1.00. There was a significant correlation (P0.001) between the age and GI. The males' GI was significantly higher (P0.001) than the females'; African-Americans showed a significantly higher GI (P0.05) than other races except for the Native-Americans.

Colgate Total toothpaste has been demonstrated to be highly effective in plaque and gingivitis control. The effect of triclosan on root caries and on the survival of dental crowns (fixed dental prosthetic treatment) has not been evaluated. In order to examine these important variables, a randomized controlled clinical trial was conducted comparing Colgate Total toothpaste with triclosan, and an identical fluoride toothpaste without triclosan.Adult subjects were randomly assigned to a test group using Colgate Total plus Whitening toothpaste with triclosan, and a control group using Colgate sodium fluoride toothpaste without triclosan. By the end of the study, following three years of product use, an evaluation was performed to compare baseline data to the three-year data for root caries and dental crown survival. Clinical root caries was evaluated by the Katz RCI- Root Caries Index. Within-treatment analysis for each dentifrice was conducted using a paired t-test. Between-treatment analysis was performed using Analysis of Covariance (ANCOVA). For fixed dental prosthetic treatment evaluation, dental crowns were dichotomized for success and failure at the end of the study. Within-treatment analysis for each dentifrice was conducted using a paired t-test. Between-treatment analysis was performed using the Bonferroni test.One-thousand, three-hundred, and fifty-seven subjects (1,357) completed the study. Regarding root caries, at termination of the study the Colgate Total group presented a mean score of 1.14 +/- 1.75 and a +5.6% change from baseline, while the sodium fluoride toothpaste presented a mean of 1.25 +/- 1.88 and a +43.2% change from baseline (p0.001). The adjusted mean root caries increment was 0.07 +/- 0.03 for the Colgate Total group, and 0.38 +/- 0.03 for the sodium fluoride toothpaste group (p0.001). Regarding crowns, at termination of the study the Colgate Total group presented a mean score of 5.38 +/- 3.70 and a +1.1% change from baseline, while the sodium fluoride toothpaste without triclosan presented a mean of 5.75 +/- 3.86 and a +3.8% change from baseline (p0.001). The mean (adjusted for multiple comparisons) dental crowns failure increment was 0.09 +/- 0.03 for the Colgate Total group, and 0.31 +/- 0.02 for the sodium fluoride toothpaste group (p0.001).A comparison between the two study groups revealed a statistically significant difference for root caries and dental crown failure scores, both favoring the triclosan toothpaste (Colgate Total). The significantly lower root caries and observed dental crown failure scores among the Colgate Total toothpaste users indicate an effect of the triclosan and the copolymer system. These results are important and could provide a strong and valuable public health measure.

The objective of this independent, double-blind, seven-day clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% CPC for controlling dental plaque relative to that of a control mouthrinse without 0.05% CPC.Adult male and female subjects from the San Juan, Puerto Rico area reported to the clinical facility, having refrained from any oral hygiene procedures for 12 hours, and from eating, drinking, and smoking for four hours, for an assessment of the oral soft and hard tissues and a baseline dental plaque evaluation. Qualifying subjects were randomly assigned into one of the two treatment groups, and were provided with their assigned mouthrinse, an adult soft-bristled toothbrush, and a commercially available fluoride toothpaste for home use. Over the seven-day period of home use, during which there were no restrictions regarding diet or smoking habits, subjects were instructed to brush their teeth for one minute twice daily (morning and evening) with the toothbrush and toothpaste supplied, to rinse their mouths with water after brushing, and then to rinse with 15 ml of their assigned mouthrinse for one minute before expectorating. The use of other oral hygiene products or procedures, such as floss or interdental stimulators, was not permitted during the study. After seven days of product use, subjects returned to the clinical facility having followed the same restrictions with respect to oral hygiene procedures, eating, and drinking as prior to the baseline examination, and the oral soft and hard tissue assessments and dental plaque evaluations were repeated. Comparisons between treatment groups with respect to baseline-adjusted Plaque Index scores at the seven-day examination were performed using Analyses of Covariance, por = 0.05.Forty-eight subjects complied with the protocol and completed the study. Results demonstrated that, after seven days of product use and 12 hours after rinsing, both the CPC mouthrinse group and the control mouthrinse group exhibited statistically significant reductions in whole-mouth Plaque Index scores (25.3% and 6.6%, respectively), in Plaque Index scores measured at interproximal sites (51.3% and 32.9%, respectively), and in Plaque Severity Index scores (43.5% and 25.4%, respectively). Relative to the control mouthrinse, the 0.05% CPC mouthrinse group exhibited statistically significant greater reductions in whole-mouth plaque scores (15.9%), in Plaque Index scores measured at interproximal sites (23%), and in Plaque Severity Index scores (17%). As the measurements were made 12 hours after final product use, the results also demonstrate that the CPC mouthrinse provides 12-hour protection against plaque accumulation in individuals with existing plaque.The overall results of this double-blind clinical study support the conclusion that after seven days of product use, a mouthrinse containing 0.05% CPC provides significantly greater efficacy for reducing dental plaque 12 hours after use, than does a control mouthrinse without 0.05% CPC.

The objective of this independent, double-blind, seven-day clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% cetylpyridinium chloride (CPC) in preventing dental plaque build-up relative to that of a control mouthrinse without 0.05% CPC.Adult male and female subjects from the São Paulo, Brazil area reported to the clinical facility, having refrained from any oral hygiene procedures for 12 hours, and from eating, drinking, and smoking for four hours, for an assessment of the oral soft and hard tissues and a baseline dental plaque evaluation. Subjects qualifying for participation received a complete dental prophylaxis. Qualifying subjects were randomly assigned into one of the two treatment groups and were provided with their assigned mouthrinse, an adult soft-bristled toothbrush, and a commercially available fluoride toothpaste for home use. Over the seven-day period of home use, during which there were no restrictions regarding diet or smoking habits, subjects were instructed to brush their teeth for one minute twice daily (morning and evening) with the toothbrush and toothpaste supplied, to rinse their mouths with water after brushing, and then to rinse with 15 ml of their assigned mouthrinse for one minute before expectorating. The use of other oral hygiene products or procedures, such as floss or interdental stimulators, was not permitted during the study. After seven days of product use, subjects returned to the clinical facility having followed the same restrictions with respect to oral hygiene procedures, eating and drinking, as prior to the baseline examination, and the oral soft and hard tissue assessments and dental plaque evaluations were repeated.Forty-three subjects complied with the protocol and completed the study. Results demonstrated that after seven days of product use, mean plaque levels were statistically significantly lower (p0.05) than the pre-prophylaxis levels for both treatment groups. The mean plaque level for the CPC mouthrinse group was 46.1% of the pre-prophylaxis plaque level, whereas the mean plaque level for the control mouthrinse group was 75.5% of the pre-prophylaxis plaque level. The results demonstrate a statistically significant reduction in plaque build-up for the CPC mouthrinse group (29.3%) as compared to the control group.The overall results from this double-blind clinical study support the conclusion that, after seven days of product use, a mouthrinse containing 0.05% CPC provides significantly greater efficacy in preventing dental plaque build-up than a control mouthrinse without 0.05% CPC. As measurements were made 12 hours after final product use, the results also demonstrate that the CPC rinse provides 12-hour protection against dental plaque build-up.

The objective of this independent, double-blind, parallel, six-week clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% cetylpyridinium chloride (CPC) for controlling established dental plaque and gingivitis relative to that of a control mouthrinse without CPC.Adult male and female subjects from the Maceió, Brazil area reported to the clinical facility, after having refrained from any oral hygiene procedures for 12 hours, and from eating, drinking, and smoking for four hours, for an assessment of the oral soft and hard tissues, and for a baseline gingivitis and dental plaque evaluation. Qualifying subjects were randomly assigned to one of the two treatment groups, and were provided with their assigned mouthrinse, and an adult soft-bristled toothbrush and toothpaste for home use. Over the six-week period of home use, during which there were no restrictions regarding diet or smoking habits, subjects were instructed to brush their teeth for one minute twice daily with the supplied toothbrush and a commercially available fluoride toothpaste, to rinse their mouths with water after brushing, and then to rinse with their assigned mouthrinse for one minute before expectorating. The use of any other oral hygiene products or procedures, such as floss or interdental stimulators, was not permitted during the study. After six weeks of product use, subjects returned to the clinical facility, having followed the same restrictions with respect to oral-hygiene procedures, eating and drinking, as with the baseline visit, and the oral soft and hard tissue assessments and gingivitis and dental plaque evaluations were repeated.One-hundred and ten subjects complied with the protocol and completed the study. With regard to supragingival plaque, after six weeks of product use, the subjects using the 0.05% CPC mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Plaque Index scores (32.1%), in Plaque Index scores measured at interproximal sites (31.3%), and in Plaque Severity Index scores (84.8%). Subjects using the control mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Plaque Index scores (7.0%), in Plaque Index scores measured at interproximal sites (6.4%), and in Plaque Severity Index scores (24.5%). When compared to the control mouthrinse group, the 0.05% CPC mouthrinse group presented statistically significant greater reductions in whole-mouth Plaque Index scores (27.9%), in Plaque Index scores measured at interproximal sites (27.9%), and in Plaque Severity Index scores (81.1%) after six weeks of product use. With regard to gingivitis, after six weeks of product use, subjects using the 0.05% CPC mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Gingival Index scores (25.0%), in Gingival Index scores measured at interproximal sites (25.3%), and in Gingivitis Severity Index scores (42.4%). Subjects using the control mouthrinse exhibited statistically significant reductions from baseline in whole-mouth Gingival Index scores (6.5%), in Gingival Index scores measured at interproximal sites (5.5%), and in Gingivitis Severity Index scores (11.6%). When compared to the control mouthrinse group, the 0.05% CPC mouthrinse group presented statistically significant greater reductions in whole-mouth Gingival Index scores (19.8%), in Gingival Index scores measured at interproximal sites (20.7%), and in Gingivitis Severity Index scores (35.5%) after six weeks of product use.The results of this double-blind, parallel, six-week clinical study support the conclusion that a mouthrinse containing 0.05% CPC is efficacious for controlling established dental plaque and gingivitis. As measurements were conducted 12 hours after product use, the results also demonstrate that the 0.5% CPC mouthrinse provides 12-hour protection against plaque and gingivitis.

This paper presents the results of one of two eight-week dentin hypersensitivity clinical studies in which the efficacy of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a benchmark commercial toothpaste containing 2% potassium ion, dosed as 3.75% potassium chloride, and 1450 ppm fluoride as sodium fluoride (NaF).An eight-week clinical study, with seventy-seven patients, was conducted in Mississauga, Canada using a double-blind, stratified, two-treatment design. Tactile sensitivity assessments, as well as air blast sensitivity assessments, were used to compare the efficacy of the two products.This clinical study demonstrated that the new toothpaste, containing 8.0% arginine and 1450 ppm MFP in a calcium carbonate base, provided a significant reduction in dentin hypersensitivity when used over a period of eight weeks. The study also showed that this new arginine toothpaste provided significantly greater reductions (p0.05) in dentin hypersensitivity in response to tactile (16.2%, 22.4%, and 21.4%) and air blast (16.2%, 29.2%, and 63.4%) stimuli than the benchmark commercial toothpaste containing 2% potassium ion and 1450 ppm NaF in a silica base, after two, four, and eight weeks of product use, respectively.A new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), provides significantly greater hypersensitivity relief (p0.05) compared to a commercial sensitive toothpaste containing 2% potassium ion after two, four, and eight weeks of product use.

To evaluate the clinical efficacy in reducing dentin hypersensitivity of a professional desensitizing paste containing 8% arginine and calcium carbonate relative to that of a commercially-available pumice prophylaxis paste when applied pre-procedurally to a professional dental cleaning (dental prophylaxis).This was a single-center, parallel group, double-blind, stratified clinical study, conducted in Langhorne, Pennsylvania. Adult male and female subjects who presented a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline hypersensitivity scores and randomly assigned within strata to one of two treatment groups. The two treatment groups were: (1) a Test paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Co.); and (2) a Control paste, Nupro pumice prophylaxis paste (Dentsply Professional). Subjects had their assigned paste applied immediately before receiving a professional dental cleaning procedure. After the completion of the dental cleaning procedure, tactile and air blast dentin hypersensitivity examinations were again performed following the same methodology employed for the baseline hypersensitivity examinations.45 subjects completed the study. At the final hypersensitivity examinations, conducted immediately after the completion of the dental cleaning procedure, subjects assigned to the test group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean tactile (132.1%) and air blast hypersensitivity scores (48.6%). Additionally, subjects assigned to the control group exhibited a statistically significant hypersensitivity improvement from baseline with respect to baseline-adjusted mean air blast hypersensitivity scores (13.9%). The hypersensitivity improvement from baseline indicated for the control group for mean tactile hypersensitivity scores (21.7%) was not statistically significant. At the final hypersensitivity examinations, statistically significant differences were indicated between the test group and the control group with respect to baseline-adjusted mean tactile (110.0%) and air blast hypersensitivity scores (41.9%).

To determine the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate relative to that of a commercially-available pumice prophylaxis paste in reducing dentin hypersensitivity instantly after a single application following a dental scaling procedure and to establish the duration of sensitivity relief over a period of 4 weeks and 12 weeks.This was a single-center, parallel group, double-blind, stratified clinical study conducted in San Francisco, California, USA. Qualifying adult male and female subjects who presented two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10-50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline hypersensitivity scores and randomly assigned within strata to one of two treatment groups: (1) A Test Paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Co); and (2) A Control Paste, Nupro pumice prophylaxis paste (Dentsply Professional). Subjects received a professionally-administered scaling procedure, after which they were re-examined for tactile and air blast dentin hypersensitivity (Post-Scaling Examinations). The assigned pastes were then applied as the final step to the professional dental cleaning procedure. Tactile and air blast dentin hypersensitivity examinations were again performed immediately after paste application. Subjects were provided with a commercially-available non-desensitizing dentifrice containing 0.243% sodium fluoride (Crest Cavity Protection, ProcterGamble Co.) and an adult soft-bristled toothbrush and were instructed to brush their teeth for 1 minute, twice daily at home using only the toothbrush and dentifrice provided, for the next 12 weeks. Subjects returned to the testing facility 4 and 12 weeks after the single application of Test or Control paste, having refrained from all oral hygiene procedures and chewing gum for 8 hours and from eating and drinking for 4 hours, prior to each follow-up visit. Assessments of tactile and air blast hypersensitivity, and examinations of oral soft and hard tissue were repeated at these 4- and 12-week examinations.68 subjects completed the 12-week study. No statistically significant differences from baseline scores were indicated at the Post-Scaling Examinations for either the Test Paste or Control Paste groups. Immediately following product application and 4 weeks after product application, subjects assigned to the Test Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (44.1% and 45.9% respectively) and mean tactile hypersensitivity scores (156.2% and 170.3% respectively). At the same time points, subjects assigned to the Control Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (15.1% and 8.9% respectively) and mean tactile hypersensitivity scores (43.1% and 8.3% respectively). Immediately following application of the assigned paste and 4 weeks later, the Test Paste group demonstrated statistically significant reductions in dentin hypersensitivity with respect to baseline-adjusted mean air blast (34.1% and 40.6% respectively) and mean tactile hypersensitivity scores (79.0% and 149.6% respectively), compared to the Control Paste group. No statistically significant differences were exhibited between paste groups at the Post-Scaling and 12-week examinations with respect to mean tactile and baseline-adjusted mean air blast hypersensitivity scores.

The objective of this monadic clinical study was to evaluate the reduction in tooth sensitivity among patients who used the Colgate 360 degrees Sensitive toothbrush during an 8-week period.Adult men and women from the northern New Jersey area were required to present two teeth that exhibited sensitivity both to tactile stimulation using the Yeaple Probe and to thermal stimulation using an air blast delivered by a standard dental-unit syringe. After examination of the oral soft and hard tissues, qualifying patients were provided with a Colgate 360 degrees Sensitive toothbrush and a supply of a commercially available, nonsensitive fluoride toothpaste, and instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the toothbrush and dentifrice provided. No other oral hygiene practices were permitted during the course of the study. After 4 weeks and again after 8 weeks of product use, patients returned to the dental clinic for follow-up examinations of tactile and thermal sensitivity of the baseline-designated sensitive teeth. Examinations of the oral soft and hard tissues also were performed at these followup visits.At the 4-week examinations, patients exhibited a statistically significant 5.49-unit increase in tactile sensitivity score and a statistically significant 0.77-unit decrease in thermal sensitivity score, both indicative of improvements in tooth sensitivity. At the 8-week examinations, patients exhibited a statistically significant 13.78-unit increase in tactile sensitivity score and a statistically significant 1.85-unit decrease in thermal sensitivity score, again both indicative of improvements in tooth sensitivity.It can be concluded that brushing sensitive teeth with the new Colgate 360 degrees Sensitive toothbrush will result in a decrease in tooth sensitivity and this decrease in tooth sensitivity will increase over time.

The objective of this independent, double-blind, overnight clinical study was to assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste) for the overnight control of oral malodor and plaque microflora, relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste).After a five-day period using a supplied commercially available fluoride toothpaste, adult male and female subjects from the Chengdu, China area reported to the clinical facility in the evening, after having refrained from the use of all oral hygiene procedures, as well as eating and drinking, for at least six hours. Following an assessment of the oral soft and hard tissues, subjects were evaluated for baseline oral malodor by a panel of four trained judges using a nine-point hedonic scale. Plaque samples (baseline) from the teeth on the left side of subjects' mouths were also collected. Subjects who presented a mean baseline oral malodor score between 6.0 and 8.4 were stratified according to their oral malodor score and randomly assigned within strata to one of the two treatment groups. Subjects were provided with their assigned dentifrice and instructed to brush their teeth on the left side of their mouth only, for one minute under supervision. Subjects returned to the testing facility the following morning for an overnight evaluation, having refrained from the use of all oral hygiene procedures, and from eating and drinking. An oral malodor assessment was performed, plaque samples were collected from the teeth on the right side of the mouth, and a final oral soft and hard tissue evaluation was performed.Eighty-one (81) subjects completed the study. At the overnight evaluation, subjects in the triclosan/copolymer/fluoride dentifrice group and the fluoride dentifrice group presented mean oral malodor scores of 4.91 and 6.86, respectively. Relative to the fluoride dentifrice group, at the overnight evaluation the triclosan/copolymer/fluoride dentifrice group presented a statistically significant 28.4% reduction in oral malodor scores. Additionally, at the overnight evaluation, subjects in the triclosan/ copolymer/fluoride dentifrice group and the fluoride dentifrice group presented geometric mean microbial colony forming unit (CFU) scores of 3.15 and 6.07, respectively. Relative to the fluoride dentifrice group, at the overnight evaluation the triclosan/copolymer/ fluoride dentifrice group presented a statistically significant 49.5% reduction in microbial CFU scores.The overall results of this double-blind clinical study support the conclusion that a single evening's use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides statistically significantly lower levels of overnight (12-hour) oral malodor and plaque microflora when compared to a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.

To assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste-Test Dentifrice) for controlling established supragingival plaque and gingivitis, relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste-Control Dentifrice).Following a baseline examination for supragingival plaque and gingivitis, qualifying adult male and female subjects from the Barcelona, Spain area were randomized into two treatment groups. Subjects were given a complete oral prophylaxis and instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were repeated after three months and six months of product use.Ninety-four (94) subjects complied with the protocol and completed the study. Relative to the Control Dentifrice group, the Test Dentifrice group presented statistically significantly lower whole-mouth plaque index and gingival index scores (18.6% and 15.8%, respectively) after three months of product use. Similarly, relative to the Control Dentifrice group, the Test Dentifrice group exhibited statistically significant reductions in plaque index and gingival index scores measured on proximal sites (17.0% and 16.3%,respectively), and statistically significant reductions in plaque severity index and gingivitis severity index scores (22.2% and 46.9%, respectively) after three months of product use. Relative to the Control Dentifrice group, the Test Dentifrice group presented statistically significantly lower whole-mouth plaque index and gingival index scores (23.4% and 21.3%, respectively) after six months of product use. Similarly, relative to the Control Dentifrice group, the Test Dentifrice group exhibited statistically significant reductions in plaque index and gingival index scores measured on proximal sites (21.1% and 23.0%, respectively), and statistically significant reductions in plaque severity index and gingival severity index scores (27.1% and 64.5%, respectively) after six months of product use.The overall results of this double-blind clinical study, conducted in accordance with the quantitative criteria established by the American Dental Association, support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base is efficacious for the control of established supragingival plaque and gingivitis.