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Purpose: To compare charcoal-containing dentifrices (CDs) to non-charcoal containing dentifrices (NCDs) through the following experiments: potentially available fluoride, 1-minute fluoride release, pH, cytotoxicity, heavy metals, enamel fluoride uptake (EFU) and relative dentin abrasivity (RDA). Methods: Nine fluoride dentifrices; six CDs and three NCDs were tested (n= 3) for available fluoride, the amount of fluoride released within 1 minute, pH cytotoxicity, heavy metals, EFU and RDA. Four CDs and 1 NCD contained sodium fluoride (NaF) as the active ingredient whereas two dentifrices contained stannous fluoride (SnF2; 1 CD and 1 NCD), and two dentifrices contained disodium monofluorophosphate (Na2FPO3, Or Na2MFP; 1 CD and 1 NCD). Available samples were homogenized and diluted to l-in-100 in deionized water (DIW). Release samples were prepared as l-in-4 homogenized dilutions by mass in DIW. Available and release samples were measured in triplicate (n= 3) via fluoride ion-selective electrode (F-ISE) and ion chromatography (IC). ANSI/ADA 130 was followed for pH. L929 cells were cultured using the lactate dehydrogenase (LDH) assay and ISO 10993-5 Annex C MTT cytotoxicity test. Heavy metals testing was performed using a hydrofluoric acid digestion sample preparation method followed by inductively coupled plasma mass spectrometry (ICP-MS) detection. EFU was performed on enamel specimens that underwent treatment with a CD slurry (l-in-4 dilution) following Test Method #40 of FDA Monograph 21. RDA was performed following ISO 11609 Annex A and the Hefferren method. Data was analyzed using one-way ANOVA followed by post-hoc tests (α= 0.05). Results: Available fluoride for all nine dentifrices was between ~93-102% of the labeled amount. The amount of fluoride released after 1 minute of homogenous mixing ranged between 75-107% of the labeled amount. The pH values of the nine dentifrices ranged from 6.5 to 7.7. Charcoal did not significantly contribute to cytotoxicity in L929 cells. The concentrations of each heavy metal (Hg, Cd, As and Pb) present in each of the nine dentifrices were < 1 ppm, indicating trace amounts. The CDs were not significantly more abrasive than the NCDs. The SnFi CD had the highest EFU value (644.2 ±131.7 ppm) followed by the NaF CD and the NaoMFP CD at 492.2± 69.5 ppm and 140.1± 28.1 ppm, respectively. [ABSTRACT FROM AUTHOR]

Purpose: To examine the relationship between remineralization of incipient root dentin lesions and the presence of polymicrobial biofilms, as well as examine changes in microbial composition. Methods: Bovine root dentin disks used as specimens for biofilm formation, were cultured using saliva from a single donor. Amsterdam Active Attachment biofilm model was used to grow biofilms. The culture medium was McBain 2005 with 0.2% sucrose and 0.4 ppm F as sodium fluoride. After cultivation for 48 hours to achieve demineralization, a control group (n=10) was obtained and the other specimens were further cultured for 336 hours in two types of remineralization culture medium, with sucrose (S+) and without sucrose (S-), through continuous anaerobic incubation (10% CO2,10% H2, 80% N2). Then half of the specimens cultured in the S- medium were transferred to the S+ medium for an additional 48 hours resulting in three experimental groups S(+) (n=10), S(-) (n=10), and S(-)de (n=10), respectively. Experiment 1: Transverse microradiography (TMR) analysis - Immediately after respective culture treatments, integrated mineral loss (IML) and lesion depth (LD) in the dentin specimens were analyzed by TMR. Experiment 2: Microbiome analysis - Sequence data of the 16S rRNA gene of each sample was obtained using MiSeq, and partial base sequences were determined. Next-generation sequencing was performed to determine the taxonomic groups of fungi present in the biofilm samples. Results: Experiment 1: In the control group, formation of dentin demineralization lesions by polymicrobial species biofilms was confirmed. The S(-) group showed significantly decreased IML and shallower LD compared to the control group. The S(-)de group showed a significant increase in IML and LD compared to the S(-) group. Experiment 2: There were statistically significant differences in microbiome between the control group and each of the three experimental groups, both at the genus and species levels. A significant difference in genus was observed between the S(-) group and the S(-)de group. [ABSTRACT FROM AUTHOR]

Purpose: To compare toothpaste tablets containing 0.243% sodium fluoride and a conventional sodium fluoride dentifrice for gingivitis and plaque control over a 2-week period. Methods: Forty adult participants were randomized into two groups: Toothpaste tablets (Colgate Anywhere Travel Toothpaste Tablets) and conventional dentifrice (Colgate Cavity Protection). A blinded examiner measured the gingival and plaque index at baseline and after 2 weeks. A questionnaire was distributed at the end to determine overall satisfaction of the product used. Statistical analyses were performed separately for the gingival index and plaque index scores. Comparisons of the two treatment groups with respect to baseline and 2-week gingival index and plaque index scores were performed using Mann-Whitney U-test. Within-treatment comparisons of the gingival index and plaque index scores obtained at the 2-week examinations versus baseline were performed using Wilcoxon test. Results: Both groups had statistically significant improvements in plaque control at the 2-week visit (P < 0.05). There was no statistically significant difference between groups for gingival and plaque index at the 2-week visit (P > 0.05). Overall satisfaction for both products were positive while perception on "texture/foaminess" was more negative for toothpaste tablets (P = 0.001). The results showed that toothpaste tablets' short-term performance on gingivitis and plaque control was equivalent to conventional dentifrice while the "texture/foaminess" of toothpaste tablets was found to be less appealing. [ABSTRACT FROM AUTHOR]

Purpose: This 6-month study compared the effects of a smart-connected oscillating-rotating (0-R) electric rechargeable toothbrush with micro-vibrations with those of a marketed smart-connected sonic rechargeable toothbrush for the reduction of gingivitis and plague. Methods: In this single-center, examiner-blind, two-treatment, open-label, parallelgroup, randomized study, 110 adult subjects with evidence of gingivitis and plague were randomized to use either the O-R brush (Oral-B iO) or the sonic brush (Philips Sonicare DiamondClean). Both groups were instructed to brush twice daily with a standard sodium fluoride dentifrice. Gingivitis and plague were assessed at baseline, week 1, and week 24 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and the Rustogi Modification of the Navy Plague Index (RMNPI). Designation of gingivitis case status as "healthy" or "not healthy" was made according to the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Results: A significantly greater percentage of subjects in the 0-R brush group versus the sonic brush group transitioned from "not healthy" to "healthy" gingivitis case status at week 24 (96.4% vs. 81.8%; P= 0.029). The O-R toothbrush produced a significantly greater reduction in adjusted mean MGI score, adjusted mean GBI score, and adjusted mean number of bleeding sites than did the sonic brush (week 24, by 32.6% for MGI score, by 23.7% for GBI score, and by 26.1% for number of bleeding sites, P< 0.001). After a single use on day 1, plague removal was statistically significantly greater for the O-R brush compared to the sonic brush (P< 0.001); by week 24, the 0-R brush demonstrated greater reductions in whole mouth plague (24.6%), gingival margin plague (61.9%) and approximal region plague 25. 8% (PS ≤ 007 for all) compared to the sonic brush. [ABSTRACT FROM AUTHOR]

Purpose: To conduct a clinical evaluation of calcium lactate and sodium fluoride mouthrinses in reducing sensitivity and efficacy of color change during in-office bleaching. Methods: 75 participants were selected and divided into three groups (n= 25), according to the type of desensitizing treatment tested: calcium lactate mouthrinse prior to sodium fluoride mouthrinse before each bleaching session; daily mouthrinse with sodium fluoride; control (absence of mouthrinse). Each mouthrinse was used for 1 minute. Bleaching was performed following the same protocol in all groups, with 40% hydrogen peroxide (Opalescence Boost), in three 40-minute sessions, with a 48-hour interval between sessions. Clinical parameters such as sensitivity, gingival irritation and mouthrinse acceptability were assessed using Visual Analogue Scale (VAS) and clinical examination at two timepoints: baseline (before any treatment) and 48 hours after the end of treatment. The color was evaluated with a spectrophotometer (VITA Classical scale guide, 3D Master guide and CIEL*a*b*). The data were analyzed by generalized linear models and by one-way ANOVA. Results: There was significant color change in all groups according to the VITA Classical scale guide (P< 0.001). There was no significant difference among the groups for ΔL*, Δa*, Δb* and ΔE over time (P> 0.05). The control group presented a significant increase in sensitivity (P= 0.008). The other groups showed no significant difference between initial and final timepoints (P> 0.05). No symptoms of gingival irritation were observed in any of the groups evaluated. All desensitizing treatments presented high acceptability. Bleaching treatment was effective, regardless of association with desensitizing treatments. No treatment prevented bleaching sensitivity, but the absence of a combined desensitizing treatment led to increased sensitivity. [ABSTRACT FROM AUTHOR]

Purpose: To compare the enamel protection efficacy of a stabilized stannous fluoride dentifrice to a triclosan-containing sodium fluoride dentifrice using a 10-day in situ erosion model, in accordance with the American Dental Association Seal of Acceptance guidelines for enamel erosion control. Methods: In this single-center, doubleblind, randomized, supervised-usage, two-treatment, four-period, crossover study, healthy adult subjects were randomized to a treatment sequence involving the following products: a 0.454% stannous fluoride (1,100 ppm F) dentifrice (Procter & Gamble) and a control dentifrice containing 0.243% sodium fluoride (1,100 ppm F) and 0.3% triclosan (Colgate-Palmolive). Each study period consisted of 10 treatment days. Subjects wore an intra-oral appliance fitted with two polished human enamel samples for 6 hours per treatment day. While wearing the appliance, subjects swished with their assigned dentifrice slurry for 60 seconds twice daily and with 250 ml orange juice over a 10-minute period four times daily. After 10 days, enamel specimens were removed and measured for surface loss using contact profilometry. Results: 36 subjects were enrolled and 33 completed the study (mean age = 41.8 years). The stannous fluoride dentifrice demonstrated 90.3% less enamel loss than the NaF/triclosan dentifrice (P < 0.001) at Day 10, with median enamel loss of 0.279 µm and 2.877 µm, respectively. Both products were well tolerated. [ABSTRACT FROM AUTHOR]

Purpose: The primary aim of this study was to evaluate the gingivitis-reduction efficacy of an experimental manual toothbrush with CrissCross and tapered bristle technology in comparison with a marketed control manual toothbrush with traditional design and non-tapered bristles. In addition, the study compared the two toothbrushes for plaque-reduction efficacy. Methods: This was a randomized, controlled, parallel group, examinerblind, single-center, 4-week clinical trial with adult subjects in good general health. All subjects had presence of gingivitis (at least 10 bleeding sites). The subjects were randomly assigned to one of two treatment groups: a manual toothbrush having CrissCross and tapered bristle technology (tapered group: Oral-B CrossAction Ultrathin manual toothbrush); or a traditional flat-trim design and regular non-tapered bristles (control group: Oral-B Indicator Soft 35 manual toothbrush). Subjects were instructed to brush twice-daily for 4 weeks with their assigned brush and a standard sodium fluoride dentifrice. At baseline, Week 2, and Week 4, gingivitis was assessed using the Mazza Modification of the Gingival Bleeding Index (Mazza GI) and pre-brushing whole-mouth plaque was measured using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Results: 100 subjects (50 per group) were randomized to treatment and assessed at baseline, and 97 subjects (48 in the tapered group and 49 in the control group) completed the study. At both Weeks 2 and 4, both groups showed a significant (P< 0.005) reduction versus baseline in Mazza GI and number of bleeding sites, and the tapered group showed a significantly (P< 0.001) greater reduction from baseline for both these assessments compared to the control group. By Week 4 the tapered group showed a reduction from baseline of 17.9% in Mazza GI and 38.5% in the number of bleeding sites; the corresponding figures for the control group were 7.5% and 12.6%, respectively. Both groups showed a significant (P< 0.001) reduction versus baseline in TMQHPI by Week 4, with no significant (P=0.06) between-group difference. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effects of different white spot lesion (WSL) treatments associated with dental bleaching on the fluorescence of dental enamel. Methods: 80 flat enamel disks (3 mm diameter and 1 mm thick) were obtained from bovine incisors. The initial fluorescence (fluorescent emission or Delta E*ab- FL units) of the specimens was measured using a spectrophotometer. Artificial caries was created in all specimens, and the measurements were repeated. The specimens were divided into four groups according to the treatment applied (n = 20): CON (control) - immersion in ultrapure water for 8 weeks; SAL - immersion in artificial saliva for 8 weeks; FL - daily application of 0.05% sodium fluoride for 1 minute/artificial saliva for 8 weeks; and ICON - resin infiltration (Icon). After the treatments, the assessments were repeated. Dental bleaching using 35% hydrogen peroxide gel was performed on all specimens for 30 minutes, and the measurements were made again after 7 days. Data were submitted to ANOVA and Tukey tests across the treatments for each moment of evaluation. Results: Fluoride and saliva remineralization were not able to change enamel fluorescence, even after bleaching. Only resin infiltration increased the enamel fluorescence; however, after bleaching, all groups presented similar values. Icon increased translucency immediately after application, but bleaching reduced it to its initial values. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of whitening mouthrinses used before toothbrushing on enamel microhardness and wear. Methods: 80 polished bovine enamel specimens were randomly assigned into four groups according to the mouthrinses tested (n=20): PW: Plax Whitening - 1.5% hydrogen peroxide (HP); LW: Listerine Whitening Pre-Brush Rinse - 2% HP; U: Ultradex - Chlorine dioxide; C: Control - Artificial saliva. The specimens were immersed in the mouthrinses for 1 minute and brushed with 10 strokes, using a dentifrice containing sodium fluoride. After treatments, they were immersed in artificial saliva for 30 minutes. A total of 540 cycles were performed simulating 9 months of use. Enamel surface was assessed with a Knoop microhardness tester and by a contact profilometer before and after treatments to obtain the surface microhardness (KHN) and enamel loss (pm) values. The specimens were immersed in artificial saliva for an additional 30 days and microhardness was measured again. Data were analyzed by ANOVA and Tukey's tests (5%). Results: Significant differences were observed in KHN (P= 0.0001) and wear (P= 0.0001). Results of Tukey's for KHN: U-320.08±13.86a, PW-323.58±32.75a, LW-331.66±24.74a, C- 354.24± 16.40b. Wear (Ām): PW-10.03±0.94a, LW-9.92±0.81a, U-8.88± 1,02b, C-6.56±0.91c. Groups followed by the same letters do not present significant differences. After 30 days in saliva, there was no significant difference for SMH among the groups. [ABSTRACT FROM AUTHOR]

Purpose: To compare the amount of fluoride release and re-release of three different restorative materials. Methods: The three restorative materials included a resin-based composite (Z100TM, 3M-ESPE), a resin-modified glass ionomer cement (VitremerTM, 3M-ESPE) and a bioactive material (Activa Bioactive-RestorativeTM, Pulpdent,). Ten disks were fabricated from each material. The disks were immersed in deionized water and stored. Samples were taken from each vial on Days 1,7, 14 and 30 for fluoride ion analysis. Each disk was then exposed to 2.0% neutral sodium fluoride gel (0.9% fluoride ion, Dentsply), immersed in deionized water and stored. Samples were taken on Days 1,7, 14 and 30 for fluoride ion analysis utilizing a fluoride-specific ion-analyzer. Results: Z100 released less fluoride on Days 1 (P< 0.001), 7 (P= 0.001) and 14 (P< 0.022) for Phase I (initial release) than Phase II (re-release). Vitremer and Activa released less fluoride on Days 7, 14 and 30 (P< 0.001) for Phase II than Phase I. For all intervals of Phase I, Vitremer released the most fluoride, Activa released the second most, and Z100 released the least. These results were the same for Days 7, 14 and 30 of Phase II. The level of fluoride release from Activa was less than that of Vitremer, and greater than that of Z100 for all intervals of Phase I. The results were the same for all but one interval of Phase II. (Am J Dent 2017;30:305-308). [ABSTRACT FROM AUTHOR]

Purpose: To determine if pit-and-fissure sealants with microencapsulated remineralizing agents with sustained release of fluoride, calcium and phosphate ions could promote enamel fluoride uptake by demineralized tooth structure. Methods: Sealants that contained 5 w/w% microcapsules with aqueous solutions of 5M Ca(N03)2 or 0.8M NaF or 6.0M K2HP04 or a mixture of all three were prepared. Ion release profiles were measured as a function of time. Enamel fluoride uptake by demineralized tooth structure was determined. Results: Sustained release of fluoride, calcium and phosphate ions from a sealant was demonstrated. Fluoride uptake by demineralized enamel was significantly increased compared to a control sealant manufactured without microcapsules (P< 0.01). Bovine enamel that contained 2.2±2.1 pg F/g of enamel prior to exposure to a sealant without microcapsules had 2.3±0.5 after 90 days. Enamel exposed to sealant with 5w/w% NaF microcapsules went from 3.5±3.5 pg F/g of enamel prior to exposure to 148±76 after 90 days. Enamel exposed to sealant with 2 w/w% NaF, 2 w/w% Ca(N03)2 and 1 w/w% K2HP04 microcapsules went from 1.7±0.7 pg F/g of enamel prior to exposure to 190±137 after 90 days. [ABSTRACT FROM AUTHOR]

Purpose: To compare the anti-gingivitis effect of a power toothbrush relative to a manual toothbrush control. Methods: This was a 3-month, randomized and controlled, single-center, parallel group, examiner-blinded clinical study. 123 Chinese adults in good general health and with at least 15 gingival bleeding sites, as measured by the Gingival Bleeding Index, were enrolled into the study. At baseline, pre-treatment gingivitis levels were assessed using the Mazza Bleeding Index. Subjects were then randomly assigned to receive either an oscillating-rotating power toothbrush [Oral-B Professional Care 7000 (D17u/EB17)] or a flat-trim manual toothbrush with tapered filaments (Lion Dentor Systema). Subjects brushed at home twice-daily with their assigned toothbrush and a marketed sodium fluoride dentifrice (Crest Cavity Protection dentifrice), and were reevaluated at Months 1, 2, and 3. Results: 113 evaluable subjects completed the study. Both groups showed significant reductions in gingivitis from baseline for all time points measured (P< 0.001). At Months 1, 2 and 3, the power toothbrush demonstrated significantly greater gingivitis reductions of 7.11%, 9.20% and 8.47%, respectively, than the manual toothbrush (P< 0.01), and significantly fewer bleeding sites (17.3%, 23.9% and 24.3%, respectively, P< 0.05). No adverse events were reported or observed for either brush during the study. (Am JDent 2016;29:193-196). [ABSTRACT FROM AUTHOR]

Purpose: To assess the anti-plaque efficacy of an oral hygiene regimen comprised of a stannous-containing sodium fluoride dentifrice, advanced manual toothbrush, and a cetylpyridinium chloride (CPC) rinse compared to a negative control regimen. Methods: This was a 4-week randomized and controlled, parallel group, single-center, single-blind, clinical trial in generally healthy Chinese adults with existing dental plaque. Following a 1-week acclimation period and cessation of overnight oral hygiene prior to the baseline examination, overnight pre-brushing plaque levels were assessed via digital plaque imaging analysis (DPIA). Subjects were randomly assigned to either: (1) the test regimen of a stannous-containing sodium fluoride dentifrice (Crest Pro-Health Expert), an advanced manual toothbrush with Criss-Cross bristles (Crest Pro-Health manual toothbrush), and a 0.07% CPC rinse (Crest Pro-Health Multi-Protection); or (2) the negative control regimen group, a 0.243% sodium fluoride dentifrice (Crest Cavity Protection) and a soft flat trim manual toothbrush (Crest MeiLiLiangJie). Subjects returned at Week 2 and Week 4 following twice daily use of their assigned products, again following pre-visit cessation of overnight oral hygiene, for DPIA evaluation of overnight plaque levels. Results: 35 fully evaluable subjects completed the trial. At Week 2, the pre-brushing overnight average DPIA plaque scores for the advanced products regimen group were 72.4% statistically significantly lower relative to the control group (P< 0.0001). At Week 4, the mean plaque inhibition benefit provided by the regimen group was 76.8% greater than the control group (P< 0.0001). All products were well-tolerated. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of a fluoride-containing polymer-based desensitizer on prevention of root demineralization using micro-computed tomography (micro-CT). Methods: Bovine root dentin blocks were divided into four groups; no treatment (Control); 1% oxalic acid (OA); MS Coat One containing methacrylate-co-p-styrene sulfonic acid (MS polymer) and 1% oxalic acid (MSO); and MS Coat F containing MS polymer, 1% oxalic acid and 3,000 ppm sodium fluoride (MSF). A window of the dentin surface was treated with each solution. The blocks were scanned using micro-CT after demineralization (pH 4.5, 5 hours). The dentin surfaces before and after demineralization were examined by scanning electron microscopy (SEM). Fluoride ion release was measured using a fluoride ion-specific electrode. The data were statistically analyzed using one-way ANOVA and Tukey's test (a= 0.05). Results: MSF showed the lowest mineral loss (80.4±10.6 vol%.pm), which was significantly different from Control (99.4±13.0 vol%.pm), OA (91. 1±10.9 vol%.|itn) and MSO (89.1±9.2 vo!%.um). Under the SEM observations, the dentin tubules appeared to be blocked after all desensitizer treatments. After demineralization, the exposure of dentin tubules was clearer in OA and MSO compared to MSF which showed sealed dentin tubules after demineralization. Fluoride ion release was detected only in the MSF group. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. Methods: 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. Results: 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. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the antiplaque effects for 0.454% bioavailable gluconate chelated stannous fluoride (SnF₂) dentifrices versus controls by clinical model, plaque index, tooth surface and tooth type in a pooled analysis., Methods: Randomized controlled trials (RCTs) were conducted to evaluate plaque effects of SnF₂ dentifrices from the same formulation family over the past 30 years. Forty-four 4-day and longer-term (≥ 2 weeks) RCTs conducted in six countries with 3,336 subjects using Turesky Modified Quigley-Hein Plaque Index, Rustogi Modification of the Navy Plaque Index, Digital Plaque Imaging Analysis, and Silness and Löe Plaque Index were included., Results: In 13 and 11 longer-term studies assessing SnF₂ dentifrice versus a negative or positive control, respectively, standardized differences in average plaque score of -1.15 (95% CI: -1.61, -0.69) and -0.74 (95% CI: -1.20, -0.28) were observed (P ≤ 0.011), favoring SnF₂. Reductions represented a 19% and 16% benefit versus the negative and positive control, respectively. In 18 and five 4-day studies assessing SnF₂ dentifrice versus a negative (NaF/SMFP) or positive (triclosan/chlorhexidine) control, respectively, differences in average 4-day plaque score of -0.27 (95% CI: -0.31, -0.23) and -0.15 (95% CI: -0.25, -0.06) were observed (P≤ 0.001) favoring SnF₂. Reductions represented a 14% and 11% benefit versus the negative and positive control, respectively. Significant antiplaque benefits for SnF₂ dentifrice were seen regardless of clinical model, plaque index, tooth surface or type, including brushed and unbrushed surfaces (P≤ 0.049)., Clinical Significance: Bioavailable gluconate chelated SnF₂ dentifrices showed consistent plaque inhibition versus negative and positive controls across all conditions evaluated. Importantly, the effect on unbrushed surfaces illustrated the significant plaque inhibition benefit of SnF₂ beyond mechanical plaque removal., Competing Interests: All authors are employees of The Procter & Gamble Company. This work was funded by The Procter & Gamble Company., (Copyright©American Journal of Dentistry.)

To evaluate the effectiveness of a desensitizing gel for topical and home use for the treatment of dentin hypersensitivity (DH) by means of a 3-arm parallel, randomized, double blind clinical trial. Methods: 107 participants were allocated to three groups: placebo gel (PG), test gel (TG) (5% sodium fluoride, 5% potassium oxalate, 10% strontium chloride) and 2% sodium fluoride gel (FG). DH measurement was performed by a single blind examiner by means of the visual analog scale (VAS) after tactile (blunt tipped probe), thermal (air blast) and osmotic (water blast) stimulus at time intervals of baseline, 7, 15 and 30 days. Results: The greatest reductions in DH were observed for the TG, with significant differences for FG in the thermal (A= -56 vs -30) and osmotic stimuli (A= -44 vs -18). Considering the percentage of participants with moderate/severe pain at 30 days, the TG demonstrated the lowest percentages, with significant differences in comparison with the other groups in thermal and osmotic stimuli. We can conclude that the test gel showed a greater reduction in DH than fluoride 2% and placebo gel, and may be a treatment option for individuals with DH. [ABSTRACT FROM AUTHOR]

Purpose: To assess the anti-plaque and anti-gingivitis effects of a dentifrice containing 0.3% triclosan, 2% copolymer and 0.243% (1,100 ppm) sodium fluoride in subjects with moderate plaque-induced gingivitis. Methods: This was a single center, monadic study. Subjects had at least 20 teeth remaining in the functional dentition, excluding third molars. Following a baseline examination for plaque, gingival inflammation and bleeding, 75 qualified healthy adult males and females, ages 18-70 were selected to participate in the study. Dental prophylaxis was performed and subjects were provided with two tubes of toothpaste (Colgate Total) and a soft-bristle toothbrush (Colgate Wave Toothbrush). The subjects were instructed to brush twice daily using a modified Bass brushing technique. At the end of the 6- to 8-week period subjects returned for collection of clinical and subjective data. Results: 75 subjects completed the study. Both clinical and subjective reductions were significant. The results showed statistically significant reductions in plaque index, gingival inflammation and bleeding on probing. The overall conclusion was that Colgate Total was a comprehensive dentifrice that produced a significant reduction in gingivitis, plaque, and bleeding. [ABSTRACT FROM AUTHOR]

Purpose: To assess the dentin hypersensitivity-reducing effectiveness of a 0.454% stannous-containing dentifrice as compared to a marketed negative control dentifrice after the first brushing as well as after 3 days and 2 weeks of twice daily use. Methods: This was a 2-week, randomized, double-blind, parallel group, single-center clinical investigation in confirmed dentin hypersensitivity adult sufferers. At baseline, subjects were stratified by age, gender, and thermal sensitivity scores, and randomly assigned to a marketed 0.454% stannous fluoride (SnF2) dentifrice or a marketed sodium fluoride (NaF) dentifrice negative control. Following baseline assessment of tactile and thermal sensitivity via the Yeaple Probe and air-blast/Schiff Air Index evaluations, respectively, subjects brushed once on-site with their assigned test product following the same usage instructions. Post-brushing tactile and thermal sensifivity were then assessed ('Immediate' evaluation). Subjects subsequently brushed twice daily at home for a 2-week period, with the same tactile and thermal efficacy evaluations repeated at Day 3 and Week 2 post-baseline. Results: All 116 enrolled subjects completed all evaluations. The stannous fluoride dentifrice provided significantly (P< 0.0001) superior dentin hypersensitivity reduction compared to the negative control dentifrice at each time point and by both evaluation measures: superior mean relative Yeaple Probe (tactile) beneflts were 124.5% after one use, 203.8% after 3 days, and 222.5% after 2 weeks; and superior mean relative Schiff Air Index (thermal) benefits were 27.6% after a single use, 44.6% at Day 3, and 74.2% at Week 2. Both dentifrices were well-tolerated. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effects of exogenous dextranase and sodium fluoride on a S. mutans monospecies biofilm. Methods: S. mutans 25175 was grown in tryptone soya broth medium, and biofilm was formed on glass slides with 1.0% sucrose. Exogenous dextranase and sodium fluoride were added alone or together. The biofllm morphology was analyzed by confocal laser scanning microscopy. The effects of the drug on the adhesion and exopolysaccharide production by the biofilms were evaluated by scintillation counting and the anthrone method, respectively. Results: In this study, we found that the structure of initial biofilm and mature biofilm were partly altered by dextranase and high concentrations of sodium fluoride separately. However, dextranase combined with a low concentration of sodium fluoride could clearly destroy the typical tree-like structure of the biofilm, and led to less bacterial adhesion than when the dextranase or fluoride were used alone (P< 0.05). The amounts of soluble and insoluble exopolysaccharide were significantly reduced by combining dextranase with a low concentration of sodium fluoride, much more than when they were used alone (P< 0.05). These data indicate that dextranase and a low concentration of sodium fluoride may have synergistic effects against S. mutans biofilm and suggest the application of a low concentration of sodium fluoride in anticaries treatment. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the desensitizing efficacy of 2% sodium fluoride solution (NaF), diode laser (DL), a DL and NaF association and a solution of hydroxyl-ethyl-methacrylate and glutaraldehyde (HEMA-G: Gluma desensitizer) in cervical dentin hypersensitivity (CDH). Methods: 262 teeth of 24 subjects (16 females and eight males; age 21 to 64 years, mean 38 years), each having at least two CHD teeth for each quadrant, were included in this prospective, split mouth, clinical study. Teeth of each oral quadrant were randomized in four groups (SG) to study the effectiveness of NaF (SG-1), of DL (SG-2) NaF-DL combination (SG-3) and HEMA-G (SG-4). The subjects were asked to rate the sensitivity experienced during air stimulation by placing a mark on a visual analogue scale (VAS) before treatment (baseline), immediately after treatment, and after 1, and 6 months. Results: The outcomes showed a significant reduction of discomfort compared to baseline values for teeth of SG-3 immediately post treatment (82.6%) (P< 0.001), after 1 month (69.5%) (P< 0.001) and after 6 months (60.8%) (P< 0.001), respectively, compared with the reduction scores of 51.6% (P< 0.001), 29.7% (P< 0.05) and 4.7% (P> 0.05), recorded for SG-1; 72.2%, (P< 0.001), 62.5% (P< 0.001), and 47.2% (P< 0.05), recorded for SG-2; 77.4% (P< 0.001), 56.1% (P< 0.001), and 27.3% (P< 0.05), recorded for SG-4. [ABSTRACT FROM AUTHOR]

To evaluate the effect of the addition of sodium trimetaphosphate (TMP) with or without fluoride on enamel demineralization, and the hardness and release of fluoride and TMP of resin composites. Methods: Bovine enamel slabs (4×3×3 mm) were prepared and selected based on initial surface hardness (n= 96). Eight experimental resin composites were formulated, according to the combination of TMP and sodium fluoride (NaF): TMP/NaF-free (control), 1.6% sodium fluoride (NaF), and 1.5%, 14.1% and 36.8% TMP with and without 1.6% NaF. Resin composite specimens (n= 24) were attached to the enamel slabs with wax and the sets were subjected to pH cycling. Next, surface and cross-sectional hardness and fluoride content of enamel as well as fluoride and TMP release and hardness of the materials were evaluated. Data were statistically analyzed using ANOVA (P< 0.05). Results: The presence of fluoride in enamel was similar in fluoridated resin composites (P> 0.05), but higher than in the other materials (P< 0.05). The combination of 14.1% TMP and fluoride resulted in less demineralization, especially on lesion surface (P< 0.05). The presence of TMP increased fluoride release from the materials and reduced their hardness. [ABSTRACT FROM AUTHOR]

Purpose: To assess the ability of a novel multi-directional power toothbrush to control plaque and gingivitis when compared to a marketed sonic power toothbrush control. Methods: This was a randomized and controlled, examiner-blinded, parallel group, 8-week study at a single center, in adult subjects with mild-to-moderate gingivitis. Pre-treatment gingivitis levels and plaque coverage were evaluated at baseline using the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to either a novel multi-directional power toothbrush with a wireless display (Oral-B Professional Deep Sweep + SmartGuide TRICLEAN 5000, also marketed as Oral-B TriZone) or the marketed control sonic toothbrush (Philips Sonicare FlexCare). After a supervised brushing at the clinical site at baseline, subjects brushed unsupervised at home twice daily according to manufacturer instructions with the assigned test brush and standard sodium fluoride dentifrice. After 8 weeks, subjects were recalled to assess toothbrush efficacy via the MGI and GBI gingivitis and RMNPI plaque evaluations. Results: A total of 128 évaluable subjects completed the study. After 8 weeks of brushing, both test toothbrushes provided statistically significant reductions compared to baseline in mean whole mouth MGI and GBI, and in RMNPI whole mouth and interproximal (approximal) sites (P< 0.001). The novel multi-directional power brush consistently produced significantly superior anti-gingivitis and anti-plaque reductions relative to pre-treatment versus the sonic control brush: the Week 8 adjusted mean relative reductions were 30% and 29% greater for whole mouth MGI and GBI, respectively (P< 0.001); and were 44% and 77% greater for the RMNPI whole mouth and interproximal regions, respectively (P≤ 0.003). Both toothbrushes were well-tolerated. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate a stannous-containing sodium fluoride dentifrice with high cleaning silica and polychelation technology (test dentifrice) compared to a currently marketed whitening dentifrice, which carries the ADA Seal of Acceptance for whitening, for its efficacy in removing existing natural stain over a 2-week period. Methods: Two independent, randomized, positive-controlled, 2-treatment, parallel group, double-blind, 2-week studies with identical protocols were conducted in China. At baseline, subjects received an oral soft tissue (OST) examination followed by a Lobene stain examination. In each study, approximately 60 subjects having a Lobene stain composite score above 1 were randomized to one of two dentifrice products: the test dentifrice or the positive control. Subjects were instructed to brash twice daily for at least 1 minute with their assigned product. Lobene stain and OST examinations were conducted again after 2 weeks of use. Results: In both studies, the test dentifrice and the positive control dentifrice demonstrated statistically significant reductions in Lobene composite (P< 0.0001), area (P< 0.0001) and intensity (P< 0.0001) stain scores after 2 weeks of use versus baseline. At Week 2, there were no statistically significant differences in stain scores between treatment groups in either study (P> 0.12). [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the fluoride concentration in enamel after the use of different fluoride products and 48 hours after the cessation of fluoride use. Methods: 16 enamel slabs were divided and treated for 15 days as following: Group A, with an amine fluoride toothpaste and mouthrinse (1400 and 250 mg/L-1, respectively); Group B, with an amine fluoride toothpaste (1400 mg/L-1) and mouthrinse without fluoride; Group C, with a sodium fluoride toothpaste (1400 mg/L-1) and mouthrinse (250 mg/L -1 Chemical biopsy and multiple means were used to determine fluoride concentration. The data were statistically analyzed using the two-way ANOVA and Tukey HSD tests (P< 0.05). Results: After 15 days of fluoride product use, Group A samples had the highest fluoride uptake (0.19 μg mm2) (P< 0.05). 48 hours after the interruption of fluoride product usage, a higher fluoride concentration was found in Group A samples. Although all fluoride products led to an enamel uptake, amine fluoride products promoted the most effective long-term uptake. [ABSTRACT FROM AUTHOR]

Purpose: To determine the relative ability of various marketed toothpastes formulated with either stabilized stannous fluoride (SnF2), sodium fluoride (NaF), or sodium monofluorophosphate (SMFP) to protect human enamel against the initiation and progression of damage due to dietary acid attack, using a laboratory erosion cycling model. Methods: Cores of ground and polished enamel from extracted human teeth were soaked in pooled, human saliva (pellicle formation) and then subjected to erosion cycling conditions that included exposure of tooth specimens to: (1) treatments in a 1:3 slurry (w/w) of toothpastes and saliva; and (2) acid challenges using either citric acid (Study 1) or both citric and phosphoric acids (Study 2). These acids represent potentially damaging acids found in common food and drinks. Upon completion of treatments, specimens were analyzed with regard to the depth of tooth mineral removed from exposed areas of the treated specimens over the course of the study. Two studies were conducted: Study 1 included a marketed, stabilized SnF2 toothpaste vs. marketed NaF toothpastes; Study 2 tested the same stabilized SnF2 product compared to a marketed SMIFP toothpaste and a NaF control. Results: The stabilized SnF2 toothpaste included in these studies demonstrated a highly significant reduction in enamel surface loss, relative to the control, in each study: Study 1 = 65% reduction; Study 2 = 58% reduction when using citric acid and 84% reduction when using phosphoric acid. Products formulated with NaF resulted in a net loss of between +1% and -21%, with none of the NaF toothpastes performing significantly different from the control (P< 0.05, ANOVA). For the SMFP product included in Study 2, results were also not significantly different from the NaF control. In both studies, the stabilized SnF2 paste demonstrated a highly significant level of protection compared to all other test groups included in the study, regardless of the type of dietary acid challenge considered. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVMIMA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis. Methods: 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% PVMJMA 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. Results: 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. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the 8-week dentin hypersensitivity efficacy of three toothpastes: (1) a dentifrice containing 0.3% triclosan, 2.0% PVMJMA 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). Methods: 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. Results: 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 (P< 0.05). The differences between Test Dentifrice 1 and Test Dentifrice 2 were statistically significant (P< 0.05) at 4 and 8 weeks after baseline examination for tactile sensitivity scores and at 8 weeks after baseline examination for air blast sensitivity scores. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the laboratory dentin occlusion efficacy and effects on dentin permeability of a new multi-benefit dentifrice in order to gain insight into the mechanism of action of a novel technology for dentin hypersensitivity relief based on a specially-designed silica and copolymer system. Methods: Acid-etched human dentin was evaluated with confocal laser scanning microscopy (CLSM) and scanning electron microscopy (SEM) after treatment with one of the following: (1) a dentifrice containing 0.3% triclosan, 2.0% PVMIMA copolymer, 0.243% sodium fluoride with specially designed silica (Test Dentifrice 1); (2) a dentifrice containing 0.3% triclosan and the same overall silica loading as Test Dentifrice 1 but without copolymer and the specially-designed silica (Placebo Dentifrice); (3) a commercially-available dentifrice containing 0.454% stannous fluoride in a silica base with sodium hexametaphosphate and zinc lactate (Test Dentifrice 2); and (4) a commercially-available non-sensitive dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). The composition of dentin treated with either Test Dentifrice 1 or Negative Control Dentifrice was analyzed using energy dispersive x-ray (EDX) and electron spectroscopy for chemical analysis (ESCA). To highlight dentin occluding efficacy of the specially-designed silica, dentin was treated with Test Dentifrice 1 formulated with fluorescently-tagged specially-designed silica and resulting occlusion followed with CLSM. The dentin occluding abilities of Test Dentifrices 1 and 2 were compared with the Negative Control dentifrice using CLSM after a 4-day cycling model consisting of twice daily dentifrice treatment and four acid challenges. Effects of treatment with Test Dentifrices 1 or 2 on dentin permeability and subsequent resistance of occluding deposits to acid dissolution and dislodgement by pulpal pressure were assessed using hydraulic conductance. Results: Dentin specimens treated with Test Dentifrices 1 and 2 were significantly occluded compared to Placebo Dentifrice and Negative Control Dentifrice when visualized with CLSM. The level of occlusion remaining after challenge with cola was highest for dentin treated with Test Dentifrice 1 in CLSM xz views. Test Dentifrice 1 produced dentin surface deposits and tubule plugs containing silicon in addition to calcium and phosphorus as indicated by ESCA and EDX. CLSM visualization of fluorescently-tagged material confirmed occlusion by the specially-designed silica which was localized at the dentin tubule openings. Imaging of dentin by CLSM after the 4-day cycling model revealed a significantly higher amount of occluded tubules for dentin treated with Test Dentifrice 1 compared to the Negative Control Dentifrice or Test Dentifrice 2. Etched dentin treated with the Test Dentifrice 1 was significantly less permeable compared to that treated with the Negative Control Dentifrice, exhibiting over 80% reduction in dentin permeability. The occlusion provided by the Test Dentifrice 1 was maintained and provided significantly better reduction in permeability after extended pulpal pressure and acid challenge compared to dentin treated with Test Dentifrice 2. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the anticaries potential of a stabilized stannous-containing sodium fluoride dentifrice relative to appropriate control products. Methods: A series of in vitro studies was conducted using the following standard anticaries efficacy measures: (1) fluoride uptake; (2) pH cycling remineralization/inhibition of demineralization; and (3) surface microhardness. In each study, the stannous-containing sodium fluoride test dentifrice (1450 ppm F) was compared to a negative control dentifrice (0 ppm F) and a positive control fluoride dentifrice (either 1100 ppm F or 1450 ppm F). Results: Fluoride uptake: The mean fluoride uptake from both the test dentifrice and the positive control dentifrice was significantly greater than the negative control. There was no statistically significant difference between the two fluoride dentifrices, although the test dentifrice was directionally higher. pH cycling: The remineralization measured with the test dentifrice was directionally higher though not significantly different from the positive control dentifrice. Remineralization by both fluoride-containing dentifrices was significantly greater versus the negative control. Surface microhardness: The percent increase in surface microhardness measured on enamel surfaces after treatments with the test dentifrice was found to be significantly higher than that measured for the positive control and the negative control. [ABSTRACT FROM AUTHOR]

Purpose: Despite oral health improvements in many geographies, the prevalence of oral concerns, including caries, gingivitis, dentin hypersensitivity, breath malodor, calculus, and extrinsic staining remains unacceptably high across the globe. Dentifrice offers a convenient and accessible vehicle to deliver ingredients - such as antimicrobials, fluoride, and esthetic-enhancing agents - to treat a broad range of common oral conditions. Recently, a novel stannous-containing sodium fluoride (1450 ppm F) dentifrice was introduced that has been tested in the lab and/or clinically in diverse geographic regions for its impact on major oral conditions. Methods: This next-generation dentifrice, marketed as Crest Pro-Health in China and blend-a-med Pro-Expert in parts of Europe, has been extensively clinically tested in the lab and/or clinically on multiple continents in a broad range of subject populations with varying levels of disease and/or cosmetic concerns. This special issue features a few of the many laboratory and clinical investigations conducted on this formulation. Results: The findings reported here demonstrate the product's anticaries potential as well as its ability to reduce plaque, improve dentin hypersensitivity, inhibit extrinsic stain, and improve breath malodor. [ABSTRACT FROM AUTHOR]

Purpose: To compare the effectiveness of an agent that promotes deposition of amorphous calcium phosphate (Quell Desensitizer) to a commonly used product, sothum fluoride solution (Nupro Neutral), in the reduction of root sensitivity after periodontal therapy, in a prospective, convenient sample, double-blind clinical trial. Methods: Thirty patients were enrolled and treated, resulting in 40 teeth treated with the test product and 40 teeth treated with the control product. The clinical parameters tested at baseline and in the follow-up visits (1, 2, and 4 weeks after treatment) were the following: plaque index, gingival index, gingival recession, and response to mechanical and cold stimulation with airblast and ice. Patients were also asked to report the grade of pain response on a Visual Analogue Scale (VAS) on the same schedule as the clinical parameters. Results: Plaque index and gingival index were not significantly different between test and control groups throughout the study. Most recession was observed on midbuccal surfaces. Buccal surfaces evoked higher pain response compared to lingual surfaces. It was concluded that both control and test treatments reduced root sensitivity response reported with mechanical or cold stimulation. No statistically significant differences were observed when the data of both groups were compared by a Student's t-test at the 0.05 level of significance. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effectiveness of a 5% sodium fluoride (NaF) bioercdible gel to remineralize demineralized enamel. Methods: Artificial enamel lesions were created at the gingivofacial surface of 36 extracted teeth. Longitudinal sections were obtained through the lesions, photographed tinder polarized light microscopy, and the demineralized areas were quantitated. Sections were painted with an acid-protective varnish, leaving only the facial surface of the enamel lesion exposed, and positioned naturally into the tooth from which they were obtained. Teeth were randomly mounted in sets of four that simulated a natural anterior arch form. Equal numbers were subjected to a NaF gel, control gel or received no treatment, with the gel being placed and retained by the interproximal embrasures of the teeth. Hollowing 30 days exposure to artificial saliva, the lesions were photographed and quantitated in the same manner as prior to treatment. Results: The NaF gel showed significantly more remineralization than the control groups (P< 0.05), with a 68.9% (± 17.7) mean lesion remineralization. [ABSTRACT FROM AUTHOR]

Purpose: To assess whether a fluoride dose response could be detected with a relatively small sample size in a short duration using a novel randomized, double-blind study design Methods: Subjects (N=644, with ~215 per group) with a mean age of 10.4 years old (9-12 years old) used a placebo dentifrice, an 1100 ppm F dentifrice or a 2800 ppm F dentifrice for the first 9 months of the study. Subjects in the placebo group were then switched to either 1100 ppm or 2800 ppm F dentifrice for the remainder of the study, while subjects in the fluoride groups continued with their original treatment assignments. Three calibrated examiners measured visual-tactile caries as DMFS that was supplemented with a radiographic examination at baseline, 9 months and 21 months for each subject. Results: The results of this study are consistent with the previous results reported for sodium fluoride dentifrices. For all examiners, the 1100 ppm and 2800 ppm fluoride dentifrices delivered statistically significantly (P< 0.05) lower DMFS scores than the placebo control dentifrice at 9 months, while at 21 months the 1100 ppm and 2800 ppm fluoride dentifrices delivered statistically significantly lower DMFS scores compared to the both the placebo/1100 ppm and the placebo/2800 ppm dentifrice groups. In addition, one of the three Examiners observed a directional (P= 0.11) dose response (2800 ppm F < 1100 ppm F) at 9 months, while at 21 months all three examiners observed evidence of a dose response, with one examiner observing a statistically significant difference between 1100 ppm and 2800 ppm F. Caries scores on occlusal surfaces provided the strongest evidence of an 1100 ppm F vs. 2800 ppm F difference. [ABSTRACT FROM AUTHOR]

Purpose: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). Materials and Methods: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 6-10 yr-old children from the metropolitan area of Maceio, Alagoas, Brazil. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. One calibrated examiner performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. Results: Two thousand four hundred thirty-two (2,432) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 3.84 for the Test Dentifrice group, and 4.06 for the Positive Control Dentifrice group. For caries increments after 1 yr, die respective means were 2.02 for the Test Dentifrice group and 2.12 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean canes increments were 4.30 for the Test Dentifrice group, and 4.83 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 10.97% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did die dentifrice containing 0.243% sodium fluoride in a silica base. [ABSTRACT FROM AUTHOR]

Purpose: To clinically evaluate and compare 3 dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). Materials and Methods: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. Results: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores [DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1,46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2 yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base. [ABSTRACT FROM AUTHOR]

A dual-chamber dentifrice, which contains sodium fluoride (NaF) in one component and dicalcium phosphate dihydrate (dical) in the other, has been developed. The dentifrice is packaged in a dual-chamber tube and is formulated to deliver 1100 ppm F. A series of studies consisting of in vitro fluoride uptake, in vivo calcium labeling, intraoral remineralization-demineralization, and animal caries studies were performed to support the improved anticaries efficacy of this product in comparison to a sodium fluoride/silica dentifrice (NaF/silica). An in vitro fluoride uptake study comparing 1100 ppm F NaF/dical dentifrice to 1100 ppm F NaF/silica showed that NaF/dical delivered significantly more fluoride than NaF/silica, 3.72 ± 0.36 µg/cm2 versus 2.41 ± 0.10 µg/cm2. A 6-day in vivo brushing study with a 44Ca labeled NaF/dical dentifrice showed that calcium from dical penetrated demineralized enamel and was present in plaque up to 18 hrs since the last brushing. An intra-oral remineralization-demineralization study was performed to evaluate NaF/dical's ability to promote remineralization in comparison to three silica-based dentifrices containing 0, 250, and 1100 ppm F as NaF. The percent mineral changes after treatment were +20.44 ± 17.14 for NaF/dical, +9,27 ± 19.53 for 1100 ppm NaF/silica, -1.43 ± 20.57 for 250 ppm NaF/silica, and -12.36 ± 21.76 for 0 ppm F/silica. A statistical analysis showed that the dual-chamber NaF/dical dentifrice was significantly more effective than the 1100 ppm NaF/silica dentifrice at promoting remineralization. A rat caries Study was performed to evaluate NaF/dical ability to prevent caries in comparison to 1100 ppm F NaF/silica, 250 ppm F NaF/silica, silica, and dical dentifrice. The mean smooth surface caries scores were 1.6 ± 2.8 for NaF/dical, 5.5 ± 6.2 for 1100 ppm F NaF/silica, 10.6 ± 6.2 for 250 ppm F NaF/silica, 13.7 ± 4.7 for 0 ppm F/silica, and 9.5 ± 7.8 0 ppm F/dical. A statistical analysis showed that the the dual-chamber NaF/dical dentifrice was superior to all other treatments tested in preventing caries in rats. The dical dentifrice was significantly superior to the silica dentifrice in preventing caries, which indicates that dical alone exhibits anticaries efficacy. In conclusion, individual and cumulative results from the fluoride uptake, intra-oral remineralization-demineralization, and rat caries studies from the dual chamber NaF/dical dentifrice support the improved anticaries efficacy of this product. [ABSTRACT FROM AUTHOR]

PURPOSE: To provide a head-to-head comparison of the anticaries efficacy associated with two commercially-available and American Dental Association-accepted dentifrices: Crest Cavity Fighting Toothpaste with Fluoristat, containing 0.243% sodium fluoride in a silica base, and Colgate Great Regular Flavor Fluoride Toothpaste, containing 0.76% sodium monofluorophosphate in a dicalcium phosphate dihydrate base. The study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward this purpose. MATERIALS AND METHODS: The study employed a double-blind, parallel-groups, multi-center two-treatment design, and involved third, fourth, and fifth grade schoolchildren from Newark, New Jersey, and from the Cidra and Lares areas of Puerto Rico. Qualifying subjects were stratified according to age and sex, and were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by the presentation of educational films and lectures at school, by semi-annual mailings to parents, and through the periodic distribution of small novelty gifts along with the dentifrice deliveries, in order to enhance the interest and enthusiasm of study participants. Post-baseline examinations were performed after 1 and after 2 yrs of product use. Two thousand four hundred seventy-nine (2,479) subjects completed this 2-yr study. For these subjects, the mean (S.D.) DFS scores at baseline were 2.77 (3.35) for the Crest group, and 2.66 (3.18) for the Colgate group. For caries increment after 1 yr, the respective means were 1.68 (2.53) and 1.70 (2.57). After 2 yrs, the mean caries increments were 3.56 (4.11) for the Crest group, and 3.56 (4.05) for the Colgate group. RESULTS: The analysis of the 2-yr caries increment scores support the conclusion that the anticaries efficacy associated with Colgate Great Regular Flavor Fluoride Toothpaste is equivalent to that associated with Crest Cavity Fighting Toothpaste with Fluoristat, in accordance with the procedures and standards provided by the published guidelines of the American Dental Association. Further, consistent with those same standards, the results of this study serve to lend additional support to the conclusion that dentifrices formulated with sodium monofluorophosphate provide an equivalent level of anticaries efficacy as to those formulated with sodium fluoride. [ABSTRACT FROM AUTHOR]