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Background This article highlights a stabilized stannous fluoride (SnF2) dentifrice that, in addition to being efficacious against caries, gingivitis, and dentin hypersensitivity, demonstrates high-performing stain prevention and removal efficacy. Methods An in vitro stain prevention model evaluated the efficacy of Colgate TotalSF containing 0.454% SnF2 and 1% zinc phosphate compared with Crest Pro-Health Whitening Power (The Procter & Gamble Company) and a nonabrasive SnF2 gel. L*, a*, and b* values were measured to assess whiteness comparing untreated and stained teeth, and with statistical analysis. A stain removal clinical study was conducted as a randomized, double-blind, 2-cell, parallel-group design using Colgate TotalSF and nonwhitening regular fluoride toothpaste. Participants were instructed to brush twice daily for 6 weeks and were examined for Lobene Composite Stain Index scores, with statistical analysis used at a significance of P Results In an in vitro stain prevention study, Colgate TotalSF performed 26% and 35% better than a competitor paste and nonabrasive SnF2 gel, respectively. In a clinical study, Colgate TotalSF use showed statistically significant extrinsic tooth stain reductions by 17.5% (3 weeks) and 27.8% (6 weeks) relative to regular fluoride toothpaste. No adverse effects were reported. Conclusions The results indicate that the stabilized Colgate TotalSF performed statistically better than other SnF2 pastes in an in vitro study, and statistically better than a regular fluoride toothpaste in a clinical study. Practical Implications Colgate TotalSF offers an SnF2-based therapeutic dentifrice with notable performance in stain prevention and removal.

Background The authors conducted an in vitro and a clinical study to assess the effect of a toothpaste containing stannous fluoride to occlude dentin tubules and reduce dentinal hypersensitivity. Methods For the in vitro study, the authors treated the surface of human dentin specimens with test or control toothpaste slurries and then evaluated them by using various spectroscopic techniques. For the clinical study, male and female participants who met the inclusion criteria brushed their teeth twice daily for 1 minute with test or control toothpaste. The authors assessed dentinal hypersensitivity by using tactile and air blast stimuli at baseline and after 4 and 8 weeks. All statistical tests of hypotheses were 2 sided, with a significance level of α set at .05. Results Results from in vitro studies showed that the test toothpaste effectively occluded the dentinal tubules with a deposit consisting of tin, zinc, phosphate, and silicon. The test and control toothpastes occluded the tubules 82% and 35%, respectively. Clinically, at the 4- and 8-week examinations, the test toothpaste provided statistically significant (P Conclusions The in vitro results indicate the toothpaste containing 0.454% stannous fluoride effectively coated dentin surfaces and occluded patent dentin tubules. Compared with the control toothpaste, the test toothpaste provided a significant reduction in dentinal hypersensitivity after 8 weeks of product use. Practical Implications A multi-benefit option for patients with dentinal hypersensitivity.

Objective The objective of this study was to compare a stabilized stannous fluoride (SnF2) dentifrice with zinc phosphate (Colgate TotalSF) with SnF2 with zinc lactate and control fluoride dentifrices for gingivitis and plaque control over a 6-month period. Methods A total of 135 adult participants were enrolled in this study. After randomization and blinding of examiners and patients, enrolled participants were provided instructions for use of assigned dentifrice. At 3 visits (0, 3, and 6 months), various gingival and plaque indexes were collected to determine the clinical efficacy of a stabilized SnF2 dentifrice. These results were compared with a SnF2 with zinc lactate dentifrice and with a control fluoride dentifrice. Results A total of 135 participants completed the study. All groups reported statistically significant reductions in gingival inflammation and improvement in plaque control at 3- and 6-month follow-up. Both SnF2 dentifrices showed statistically significant reductions in all indexes compared with the control dentifrice (P Conclusions This study reports similar efficacy of a test dentifrice to a commercial SnF2-containing dentifrice for plaque control and reduction in gingival inflammation and provides supporting evidence that the test dentifrice maintains its clinical efficacy with change of formulation. Practical Implications This newly formulated SnF2 stabilized with zinc phosphate dentifrice may be of benefit to patients in controlling plaque biofilm and gingivitis.

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 article highlights a stabilized stannous fluoride (SnFAn in vitro stain prevention model evaluated the efficacy of Colgate TotalIn an in vitro stain prevention study, Colgate TotalThe results indicate that the stabilized Colgate TotalColgate Total

Background The objective of this study was to compare a stannous fluoride (SnF2) dentifrice (Colgate TotalSF) stabilized with zinc phosphate with a sodium fluoride control dentifrice for gingivitis and plaque control over a 6-month period. Methods One hundred adult participants were enrolled in this study conducted in Chengdu, China. After random assignment and blinding of examiners and patients, enrolled participants received instructions for use of the assigned dentifrice. At 3 visits (baseline and 3 and 6 months), the authors measured various gingival and plaque indexes to determine the clinical efficacy of the stabilized SnF2 dentifrice compared with those of the control fluoride dentifrice (2 groups). Results Ninety-eight participants completed the study. Both groups (test and control) had statistically significant reductions in gingival inflammation and improvement in plaque control at the 3- and 6-month follow-ups. In addition, the test dentifrice showed statistically significant reductions in all indexes compared with the control dentifrice (P Conclusions This study’s results show statistically significantly improved clinical outcomes for reduction of gingival inflammation and improvement in biofilm control over a 6-month period through the use of a SnF2 dentifrice stabilized with zinc phosphate when compared with results with a fluoride control dentifrice. Practical Implications This newly formulated dentifrice improves gingival health and plaque control and thereby may aid patients in attaining improved oral health.

The objective of this study was to compare a stabilized stannous fluoride (SnFA total of 135 adult participants were enrolled in this study. After randomization and blinding of examiners and patients, enrolled participants were provided instructions for use of assigned dentifrice. At 3 visits (0, 3, and 6 months), various gingival and plaque indexes were collected to determine the clinical efficacy of a stabilized SnFA total of 135 participants completed the study. All groups reported statistically significant reductions in gingival inflammation and improvement in plaque control at 3- and 6-month follow-up. Both SnFThis study reports similar efficacy of a test dentifrice to a commercial SnFThis newly formulated SnF

To evaluate the effectiveness in reducing dentin hypersensitivity (DH) of a commercial toothpaste containing 8% arginine, calcium carbonate and fluoride when applied by a dental professional immediately prior to a professional dental prophylaxis and again after subjects brushed twice daily with the toothpaste at home for 2 weeks, and additionally to assess whether the % reductions in DH observed in the study are comparable to those found in previously published pivotal studies.This clinical study was a single-center, user-blind, monadic study conducted in Mississauga, Canada. Adult subjects who presented with 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) and met all inclusion and exclusion criteria were entered into the study. Immediately following baseline assessment, qualifying subjects received a single topical application of the test toothpaste to two selected hypersensitive teeth by a dental professional using a fingertip and massage for 1 minute per tooth, after which they received a professional dental prophylaxis. Subjects then brushed at-home twice daily for 1 minute with their assigned toothpaste for a period of 2 weeks. Tactile and air blast sensitivity examinations were conducted after the dental cleaning procedure and again after 2 weeks of routine twice daily tooth brushing.39 subjects complied with the protocol and completed the clinical study. Immediately post-prophylaxis, subjects exhibited statistically significant reductions from baseline of 228.9% (P0.001) in tactile hypersensitivity and 48.9% (P0.001) in air blast hypersensitivity. Furthermore, after brushing twice daily (morning and evening) for a period of 2 weeks, subjects exhibited statistically significant reductions from baseline of 317.8% (P0.001) in tactile hypersensitivity and 90.1% (P0.001) in air blast hypersensitivity. These results are consistent with the results of previously published clinical studies, which demonstrated similar % reductions in DH to a single in-office professional application of the desensitizing prophylaxis paste and to a single direct topical self-application of the desensitizing toothpaste.The results of this clinical study, together with the results of published pivotal studies, demonstrate that a desensitizing toothpaste containing 8% arginine and calcium carbonate, with or without fluoride, provides statistically significant reductions in dentin hypersensitivity when applied by a dental professional prior to a professional dental prophylaxis. The results also demonstrate that this desensitizing toothpaste provides statistically significant reductions in dentin hypersensitivity when used subsequently as an adjunct to routine twice daily tooth brushing.

This study aimed to evaluate the anti-plaque and anti-gingivitis effects of two mouthwashes containing cetylpyridinium chloride (CPC), in comparison to negative control mouthwash. One hundred and twenty subjects were randomly assigned to study groups: test (0.075% CPC and 0.28% zinc lactate), positive control (0.07% CPC) and negative control mouthwash without CPC. All volunteers were examined by a calibrated examiner for the Quigley-Hein Plaque Index (Turesky modification) and Löe-Silness Gingival Index (GI). Gingival severity was also measured by the percentage of sites with positive gingival bleeding. During six weeks, oral hygiene consisted of brushing twice daily with a toothbrush and toothpaste and rising with their assigned mouthwash. Plaque and gingival parameters were assessed at baseline, after four and six weeks of product use. Statistical analyses were performed separately for plaque and gingival indices, by ANOVA, paired t-test and ANCOVA (α < 0.05). After 4 and 6 weeks, all mouthwashes groups presented statistically significant reductions in plaque and gingival parameters as compared to baseline. In comparison to the positive control, the test group presented additional reductions in dental plaque of 19.8% and 16.8%, after 4 and 6 weeks, respectively. For GI, the additional reductions in the test group were 9.7% and 14.3%, at 4 and 6 weeks, respectively. The test group showed additional reduction of 35.3% and 54.5% in the gingival severity, at week 4 and 6, respectively. It is concluded that the mouthwash containing CPC and zinc lactate presents significant anti-plaque and anti-gingivitis effects as compared to positive and negative control mouthwashes.

The aim of this randomized, single blinded clinical trial was to evaluate the effect of a pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and sodium fluoride (F) in the reduction of viable bacteria in oral aerosol after a dental prophylaxis with ultrasonic scaler. Sixty systemically healthy volunteers receiving dental prophylaxis were randomly assigned to one of the following experimental groups (15 per group): (i) rinsing with 0.075% CPC, 0.28% Zn and 0.05% F (CPC+Zn+F), (ii) water or (iii) 0.12% chlorhexidine digluconate (CHX), and (iv) no rinsing. Viable bacteria were collected from different locations in the dental office on enriched TSA plates and anaerobically incubated for 72 hours. The colonies were counted and species were then identified by Checkerboard DNA–DNA Hybridization. The total number of colony-forming units (CFUs) detected in the aerosols from volunteers who rinsed with CPC+Zn+F or CHX was statistically significantly (p

Objective To compare the efficacy of a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride to a matched, positive control dentifrice containing 1450 ppm fluoride in arresting and reversing early coronal caries lesions in children using Quantitative Light-induced Fluorescence (QLF). Study design 331 children from Chiang Mai, Thailand, aged 7–14 years, with one or more visible early enamel caries lesions on the upper anterior teeth, completed the study. The new dentifrice contained 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate; the matched positive control contained 1450 ppm fluoride only. Subjects brushed twice daily at home and additionally once on school days under teacher's supervision. Digital images of the upper six anterior teeth were captured at the baseline, 3- and 6-month examinations using a custom apparatus for reproducible acquisition of Quantitative Light-induced Fluorescence data. Results At the 3-month examination, the Δ Q (representing lesion volume) for the test group decreased from a mean of 28.62 at baseline to 20.53 mm 2 % and for the positive control group to 23.38 mm 2 %. The difference between groups was not statistically significant ( p = 0.055). At the 6-month examination, the Δ Q decreased for the test group to 15.85 mm 2 % and for the positive control group to 20.35 mm 2 %. The difference between groups was statistically significant ( p Conclusion A new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate, provided statistically significant superior efficacy in arresting and reversing active coronal caries lesions in children than brushing with a matched positive control dentifrice containing fluoride alone.

To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months.135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months.After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful.

A double blind, randomized, unsupervised, parallel-group clinical trial was conducted on over 5,500 children in Sichuan Province, China. This clinical trial compared the anti-caries efficacy of two test dentifrices to that of a control dentifrice.The test dentifrices contained 1.5% arginine, 1450 ppm fluoride as sodium monofluorophosphate (MFP), and an insoluble calcium compound (either dicalcium phosphate or calcium carbonate). The positive control dentifrice contained 1450 ppm fluoride as sodium fluoride (NaF), in a silica base. The children were randomly assigned one of the toothpastes, and children residing in the same household were assigned the same dentifrice to use at home, twice a day.Three calibrated dentists examined the children at baseline, as well as after one and two years of product use. After one year of product use, there were no statistically significant differences among the three groups with respect to decayed, missing, and filled teeth (DMFT) or to decayed, missing, and filled surfaces (DMFS). After two years of product use, subjects in the two test groups using the dentifrices containing 1.5% arginine, 1450 ppm fluoride as MFP, and an insoluble calcium compound had a statistically significant reduction in DMFT increments of 20.5% and in DMFS increments of 19.6% when compared to subjects in the group using the positive control dentifrice. After two years, there were no statistically significant differences with respect to DMFT or DMFS between the two groups using the dentifrices containing 1.5% arginine, 1450 ppm fluoride as MFP, and an insoluble calcium compound.The use of the two test dentifrices demonstrated significant reductions in decayed, missing, and filled teeth and surfaces, however there was no statistically significant different between the two test dentifrices clinically after two years of using the toothpastes. The results of this two-year clinical investigation support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride as MFP provide superior protection against caries lesion cavitation compared to a positive control dentifrice containing only 1450 ppm fluoride as NaF.

PURPOSE To investigate the clinical efficacy in controlling established gingivitis and dental plaque of a 1450 ppm fluoride as sodium monofluorophosphate (SMFP)/zinc-based dentifrice, as compared to a zinc-free dentifrice with 1450 ppm fluoride as SMFP after six months product use. METHODS A six-month clinical study, with eighty-six (86) subjects, was conducted in Chengdu, China, using a double-blind, randomized, parallel-group treatment design. After a baseline evaluation, study subjects were randomly assigned to one of the two study treatments: 1) 1450 ppm fluoride as SMFP/zinc-based dentifrice (Test) or 2) 1450 ppm fluoride as SMFP/zinc-free dentifrice (Negative Control). Subjects were provided with a soft bristle toothbrush and brushed their teeth twice daily (morning and evening) for one minute with their assigned dentifrice. After three months, and again after six months of product use, subjects returned to the testing facility for their followup gingivitis and plaque examinations. Statistical analyses were performed separately for the gingivitis assessments and dental plaque assessments using the appropriate statistical methods. All statistical tests of hypotheses were two-sided, and employed a level of significance of α = 0.05. RESULTS After three and six months of product use, subjects assigned to the Test treatment exhibited statistically significant (p < 0.001) reductions in gingival index and plaque index scores as compared to subjects assigned to the Negative Control treatment. CONCLUSION The results of this single-center, double-blind, parallel-group and randomized clinical study support the conclusion that a 1450 ppm fluoride as SMFP/zinc-based dentifrice provides clinically meaningful and statistically significant reductions in gingivitis (23.8%) and dental plaque (22.5%) as compared to a 1450 ppm fluoride as SMFP/zinc-free dentifrice over a six-month period of twice-daily product use.

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.

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.

A series of studies was conducted to clarify the role of DCPD in improving the effects of fluoride in the mouth. We performed plaque fluid studies to see if the use of DCPD dentifrices increases the levels of free Ca2+ ions and the DSenamel in plaque fluid. The results of these studies showed that plaque fluid was undersaturated with respect to DCPD; therefore, DCPD would dissolve in the mouth. The Ca2+ activity in plaque fluid measured 12 hours post-treatment was significantly elevated with the use of DCPD dentifrices in comparison with silica dentifrices. The use of DCPD dentifrices also increased the DSenamel of plaque fluid in comparison with a NaF/silica dentifrice. To determine whether Ca from DCPD could be detected in demineralized enamel and whole plaque after in vivo usage of a DCPD/ fluoride dentifrice, we conducted a 44Ca labeling study. Secondary Ion Mass Spectrometry (SIMS) was used to detect and measure changes in 44Ca levels in enamel before and after 6 days of in vivo treatment with a 44DCPD/fluoride dentifrice. The results showed that 44Ca from DCPD was incorporated into enamel and detected in plaque 18 hours post-treatment. The findings from these studies show that brushing with a DCPD dentifrice introduces additional, exogenous Ca into the oral environment, which fosters improved remineralization of teeth in combination with fluoride.

W. Yin , D.Y. Hu , X. Li , X. Fan , Y.P. Zhang , I.A. Pretty , L.R. Mateo , D. Cummins , R.P. Ellwood * a State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, China Colgate-Palmolive Technology Center, River Road, Piscataway, NJ, USA Dental Health Unit, Skelton House, Manchester Science Park, Manchester, UK d LRM Statistical Consulting, Hoboken, NJ, USA j o u r n a l o f d e n t i s t r y x x x ( 2 0 1 4 ) x x x – x x x

P. Srisilapanan , N. Korwanich , W. Yin , C. Chuensuwonkul , L.R. Mateo , Y.P. Zhang , D. Cummins , R.P. Ellwood f,* a Facultad de Odontologia, Universidad de Chiang Mai, Chiang Mai, Tailandia b Laboratorio Estatal Principal de Enfermedad Oral, Universidad de Sichuan, Chengdu, China c Hospital de la Municipalidad de Chiang Mai, Chiang Mai, Tailandia d LRM Consultoria en Estadistica, Hoboken, NJ, EE.UU e Centro de Tecnologia Colgate-Palmolive, River Road, Piscataway, NJ, EE.UU f Unidad de Salud Dental, Skelton House, Manchester Science Park, Lloyd St North, Manchester M15 6SH, Reino Unido

ObjectiveThe objective of this eight week, single-center, two-cell, double-blind, and randomized clinical study was to evaluate the dentin hypersensitivity reduction efficacy of a mouthwash using Pro-Argin™ Mouthwash Technology containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base (“Arginine Mouthwash”) compared to an ordinary mouthwash without any active ingredients (“Negative Control”).MethodsQualifying subjects who presented two hypersensitive teeth with a tactile hypersensitivity score between 10 and 50g of force, and an air blast hypersensitivity score of 2 or 3 participated in this study and were randomized into one of two treatment groups. Subjects brushed with the toothbrush and fluoride toothpaste provided and then rinsed with 20mL of their assigned mouthwash for 30s twice daily. Subjects refrained from eating or drinking for 30min after rinsing. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at the baseline visit and again after two weeks, four weeks and eight weeks of product use.ResultsNinety (90) subjects entered and completed the eight week study. After two weeks, four weeks and eight weeks of product use, subjects in the Arginine Mouthwash group exhibited statistically significant (p

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.

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 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.

To compare the efficacy ofa dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride in controlling established gingivitis and supragingival plaque to that of a commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a commercially available dentifrice containing 0.243% sodium fluoride.Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Mississauga, Ontario, Canada 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 eighty-two (182) subjects complied with the protocol and completed the study. Relative to the 0.243% sodium fluoride 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 supragingival plaque index scores of 26.5% and 29.4%, respectively, after six weeks of product use. Similarly, relative to the 0.243% sodium fluoride dentifrice group, the 0.454% stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 12.7% and 12.6%, respectively, after six weeks of product use. Further, relative to the 0.454% stannous fluoride/sodium hexametaphosphate/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 15.8% and 19.2%, 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, and 0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque, 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.

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.

ObjectiveTo compare the efficacy of a new dentifrice containing 1.5% arginine, an insoluble calcium compound and 1450ppm fluoride to arrest and reverse naturally occurring buccal caries lesions in children relative to a positive control dentifrice containing 1450ppm fluoride alone.Study designParticipants from Chengdu, Sichuan Province, China tested three dentifrices: a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450ppm fluoride, as sodium monofluorophosphate, a positive control dentifrice containing 1450ppm fluoride, as sodium fluoride, in a silica base, and a matched negative control dentifrice without arginine and fluoride. Quantitative Light-induced Fluorescence (QLF) was used to assess buccal caries lesions at baseline and after 3 and 6 months of product use.Results438 participants (initial age 9–13 years (mean 11.1±0.78) and 48.6% female) completed the study. No adverse events attributable to the products were reported during the course of the study. The subject mean ΔQ (mm2%), representing lesion volume, was 27.26 at baseline. After 6 months of product use, the ΔQ values for the arginine-containing, positive and negative control dentifrices were 13.46, 17.99 and 23.70 representing improvements from baseline of 50.6%, 34.0% and 13.1%. After 6 months product use, the differences between the pair wise comparisons for all three groups were statistically significant (p

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.

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 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.