Stannous fluoride forms aggregates between outer and inner membranes leading to membrane rupture of Porphyromonas gingivalis and Prevotella pallens.

Objective: Stannous has been shown to bind to free lipopolysaccharides, thus preventing them from binding to TLR receptors. This study was undertaken to determine the histomorphological mechanism of stannous binding to anaerobic bacteria. Methods: Two bacteria associated with gingivitis and advanced periodontal disease, Porphyromonas gingivalis (P. gingivalis) and Prevotella pallens (P. pallens), were cultured in 25-1,000 µM of stannous fluoride and stannous chloride for 48 h. The growth rate was estimated using absorbance OD600. Bacterial cells were then fixed and processed for transmission electron microscopy (TEM) analysis. Results: Stannous fluoride inhibited proliferation of both P. gingivalis and P. pallens in a dose-dependent manner. There was a statistically significant suppression of the growth curve starting at 100 µM for P. pallens (P = 0.050) and 200 µM for P. gingivalis (P = 0.039). TEM analysis revealed a thick layer of polysaccharides (19.8 nm) in P. gingivalis. The outer and inner membranes were clearly visible with low electron densities in both bacteria. Stannous diffused into bacterial membranes and formed precipitates in the areas spanning outer and inner membranes and below inner membranes. Precipitates varied in size ranging from 46.4 to 84.5 nm in length, and 18.4 to 35.9 nm in width. The membranes were disintegrated in the region where stannous formed precipitates. Cytosolic contents were leaked out, and in several cases, small vesicles were formed. Stannous precipitates were more abundant in numbers and larger in size in bacteria treated with high concentrations (100-300 µM) than in low concentrations (25-50 µM) of stannous fluoride. Furthermore, most of the bacteria were disintegrated in the groups treated with 100-300 µM stannous fluoride. At low concentrations (25 µM), stannous fluoride formed complexes primarily around outer membranes, to which lipopolysaccharides are anchored. Stannous chloride results showed similar trends, but it was less potent than stannous fluoride. Conclusion: Stannous fluoride can penetrate bacteria, bind to the constituents of the membrane and form precipitates between outer and inner membranes and beneath inner membranes. These large precipitates damaged the integrity of membranes and allowed cytosolic contents to be leaked out. Stannous complexes formed at the outer membranes, even at low concentrations (25 µM).

Novel findings on anti-plaque effects of stannous fluoride.

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.

Virucidal Activity of Over-the-Counter Oral Care Products Against SARS-CoV-2.

PURPOSE: The oral cavity is an important entry point for SARS-CoV-2 infection. This study tested whether four commercially available mouthrinses and dentifrices have in vitro virucidal activity against SARS-CoV-2 (=4 log10 reduction in viral titer). MATERIALS AND METHODS: One part of stock SARS-CoV-2 virus plus one part 0.3 g/l bovine serum albumin were mixed with eight parts of test product solution. After 30 s for the rinses, or 60 s for the dentifrices, the mixture was quenched in an appropriate neutralizer, serially diluted, and inoculated onto Vero E6 cells to determine viral titer. Triplicate runs were performed for each test condition with appropriate controls for test product cytotoxicity, viral interference, and neutralizer effectiveness. Test products included: 1.5% hydrogen peroxide (H2O2) rinse; 0.07% cetylpyridinium chloride (CPC) rinse; 0.454% stannous fluoride (SnF2) dentifrice A; and 0.454% SnF2 dentifrice B. RESULTS: ?The 1.5% H2O2 rinse, 0.07% CPC rinse, SnF2 dentifrice A, and SnF2 dentifrice B all produced > 4 log10 reduction in SARS-CoV-2 titer. CONCLUSION: All four test products displayed potent virucidal activity in vitro. Clinical studies are warranted to determine what role, if any, these oral care products might play in preventing transmission of SARS-CoV-2 or in the management of patients currently diagnosed with COVID-19 illness.

Effects of an oral hygiene regimen on progression of gingivitis/early periodontitis: A randomized controlled trial.

Background: Periodontal disease continues to be prevalent globally, but little clinical research has been undertaken to evaluate the long-term benefits of a daily oral hygiene regimen on progression of gingivitis/early periodontitis. The objective of this study was to evaluate the effects of an oral hygiene regimen (OHR) on the periodontal health of adults in good general health with established gingivitis and early periodontitis over 24 months. Methods: A randomized controlled trial was conducted in adults with established gingivitis, with isolated sites of probing pocket depth >4 mm. Study participants were randomized to the OHR (bioavailable stannous fluoride dentifrice, oscillating-rotating electric toothbrush, cetylpyridinium chloride rinse, and floss; P&G) or usual care products (sodium fluoride dentifrice and manual toothbrush; P&G) groups. At baseline and every 6 months, gingivitis and periodontal measures were assessed and a prophylaxis was conducted. The primary outcome was Gingival Bleeding Index-Bleeding Sites (GBI-BS). Analyses used ANCOVA at 5% significance levels. Results: A total of 107 individuals were enrolled; 87 completed the study. Mean GBI-BS, Modified Gingival Index, and Probing Pocket Depth (PPD) scores were significantly lower at each visit for the OHR versus usual care group by 28% to 39%, 12% to 18%, and 6% to 13%, respectively (p≤ 0.0009). The magnitude of reduction in median number of ≥2 mm PPD loss events for OHR versus the usual care group at 24 months was 74%. Conclusion: Long-term use of the OHR produced significant periodontal health improvements versus the usual care products.

Contexte: La maladie parodontale continue d'être prévalente sur le plan mondial, mais peu de recherches cliniques ont été effectuées pour évaluer les avantages à long terme d'un régime d'hygiène buccodentaire sur la progression de la gingivite ou de la parodontite précoce. L'objectif de cette étude était d'évaluer les effets d'un régime d'hygiène buccodentaire (RHB) sur la santé parodontale des adultes en bonne santé générale qui présentent une gingivite établie et une parodontite précoce au cours de 24 mois. Méthodologie: Un essai contrôlé randomisé a été effectué chez des adultes présentant une gingivite établie et des sites isolés de profondeurs de poches au sondage >4 mm. Les participants de l'étude ont été confiés à un groupe de RHB aléatoire (pâte dentifrice au fluorure stanneux biodisponible, une brosse à dents électrique rotative et oscillante, un rince-bouche au chlorure de cétylpyridinium et la soie dentaire; P & G) ou à un groupe de produits de soins habituels (dentifrice au fluorure de sodium et une brosse à dents manuelle; P & G). La gingivite et les mesures parodontales ont été évaluées au début de l'intervention et tous les 6 mois et une prophylaxie avait été effectuée. Le résultat primaire était l'Indice de saignement gingival­les sites de saignements (ISG­SS). L'analyse de covariance a été utilisée à des seuils de signification de 5 %. Résultats: Un total de 107 personnes ont été inscrites : 87 ont terminé l'étude. Les cotes moyennes de l'ISG­SS, de l'indice gingival modifié et des cotes de profondeurs des poches au sondage (PPS) étaient significativement plus faibles à chaque visite du groupe de RHB par rapport au groupe de soins habituels, de 28 % à 39 %, 12 % à 18 % et 6 % à 13 %, respectivement (p≤ 0,0009). L'ampleur de la réduction en nombre médian d'événements de perte de PPS ≥2 mm du groupe de RHB par rapport au groupe de soins habituels était de 74 % à 24 mois. Conclusion: L'utilisation à long terme du RHB a produit des améliorations significatives de la santé parodontale par rapport aux produits de soins habituels.

Randomized clinical trial assessing anti-gingivitis efficacy of two stannous fluoride dentifrices and zinc/arginine dentifrice.

PURPOSE: To evaluate the anti-gingivitis efficacy of two bioavailable stannous fluoride (SnF2) dentifrices versus a zinc/arginine dentifrice and a negative control dentifrice, and to compare the plaque control benefits. METHODS: This was a single-center, randomized, controlled, four-treatment, parallel-group, double-blind, 3-month clinical trial. Healthy adult subjects with gingivitis were randomly assigned to one of four different dentifrice treatment groups: SnF2 dentifrice A, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + sodium hexametaphosphate (Procter & Gamble); SnF2 dentifrice B, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + citrate (Procter & Gamble); Zn/Arg dentifrice, zinc/arginine + sodium fluoride (1,450 ppm F) (Colgate-Palmolive); negative control dentifrice, sodium monofluoro-phosphate (1,000 ppm F) + sodium fluoride (450 ppm F) (Colgate-Palmolive). Subjects brushed with their assigned treatment dentifrice and an assigned manual toothbrush (Oral-B Indicator) for 1 minute, twice daily, for the duration of the study. Gingivitis was assessed at Baseline and at Weeks 2, 4 and 12 by calculating the total number of gingival bleeding sites using the Gingival Bleeding Index, and plaque was assessed at Baseline and at Week 12 using the Turesky Modified Quigley-Hein Index. A repeated measures model was carried out across Weeks 2, 4, and 12 to determine bleeding efficacy (total number of bleeding sites). An ANCOVA with baseline plaque as the covariate was used to evaluate plaque efficacy at Week 12. RESULTS: 161 subjects were randomized (mean age= 38.8 years). 154 subjects completed the study and 153 had evaluable data at Week 12. The mean (SD) number of Baseline bleeding sites overall was 78.74 (31.16) with no significant difference between groups (P= 0.537). SnF2 dentifrice A significantly reduced the number of bleeding sites relative to the negative control dentifrice at Weeks 2, 4 and 12 by 15.4%, 13.7% and 17.2%, respectively. SnF2 dentifrice B significantly reduced the number of bleeding sites relative to the negative control dentifrice at Week 4 by 13.9% (P= 0.041). Relative to the Zn/Arg dentifrice, SnF2 dentifrice A produced significantly greater reductions in gingival bleeding sites at Weeks 2, 4 and 12 by 23.4%, 17.2% and 20.9%, respectively (P≤ 0.007). SnF2 dentifrice B produced significantly greater bleeding reductions versus the Zn/Arg dentifrice at Weeks 4 and 12 by 17.4% and 14.4%, respectively (P≤ 0.035). The Zn/Arg dentifrice did not differ significantly in the number of bleeding sites (P≥ 0.127) or plaque (P= 0.175) relative to the negative control dentifrice. Both SnF2 dentifrices significantly reduced plaque levels (P≤ 0.029) relative to both negative control dentifrice and Zn/Arg dentifrice at Week 12. All dentifrices were well tolerated. CLINICAL SIGNIFICANCE: Two different SnF2 dentifrices showed significantly reduced gingival bleeding and plaque levels relative to a Zn/arginine dentifrice.

The relative clinical efficacy of three 0.454% stannous fluoride dentifrices for the treatment of gingivitis over 3 months.

PURPOSE: To assess the safety and efficacy of three stannous fluoride (SnF2) dentifrices in the reduction of gingivitis versus a negative control dentifrice. METHODS: This was a randomized, controlled, double-blind, four-treatment parallel group study. 120 healthy adult volunteers with established gingivitis were enrolled and randomly assigned to one of four dentifrice treatment groups (30/group): 0.454% SnF2 + citrate dentifrice A; 0.454% SnF2 + sodium hexametaphosphate dentifrice B; 0.454% SnF2 + pyrophosphate dentifrice C; or 0.76% sodium monofluorophosphate negative control group. Subjects brushed with their assigned dentifrice and an assigned regular manual toothbrush (Oral-B Indicator) for 1 minute twice daily for 12 weeks. Number of gingival bleeding sites and Löe-Silness Gingival Index (LSGI) scores were assessed at baseline and at Weeks 2, 4 and 12. RESULTS: 120 subjects were enrolled and 112 completed the trial. Subjects had an average age (SD) of 39.31 (14.5) years; 67% of subjects were female. Overall baseline means (SD) were 81.2 (25.6) for number of bleeding sites and 1.51 (0.197) for mean LSGI score. Baseline disease levels were balanced across all treatment groups. At Week 2, SnF2 dentifrices A and B demonstrated a significant reduction in gingival bleeding sites versus the negative control; however, SnF2 dentifrice C was not significantly different from the negative control (P= 0.15). At Weeks 4 and 12, all SnF2 dentifrices demonstrated a significant gingival bleeding site reduction versus the negative control (P< 0.001). At Weeks 2, 4 and 12, the SnF2 dentifrices were rank ordered dentifrice A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001). The same trends were seen for LSGI scores. CLINICAL SIGNIFICANCE: In this 12-week clinical study, all 0.454% SnF2 dentifrices delivered statistically significant reductions in the number of gingival bleeding sites relative to the negative control. Importantly, statistically significant efficacy differences were observed among the three 0.454% SnF2 dentifrices, demonstrating the important role that differences in formulation have on clinical efficacy.

A clinical study to assess the effect of a stabilized stannous fluoride dentifrice on hypersensitivity relative to a marketed sodium fluoride/triclosan control.

OBJECTIVE: To evaluate the efficacy of a marketed stabilized stannous fluoride (SnF2) dentifrice in reducing dentinal hypersensitivity as compared to a marketed sodium fluoride (NaF)/triclosan dentifrice over an eight-week period. METHODS: Adults with confirmed dentinal hypersensitivity were enrolled in this randomized and controlled, parallel group, double blind, eight-week, single-center clinical trial. Random assignment to one of two dentifrice test groups via age, gender, and thermal sensitivity of enrolled test teeth was performed at baseline, with subjects assigned to twice-daily unsupervised brushing with either the marketed SnF2 dentifrice (Oral-B Pro-Expert, 0.454% SnF2 plus 0.077% NaF) or the marketed 0.32% NaF with 0.3% triclosan/copolymer dentifrice control (Colgate Total Advanced). Tactile sensitivity (Yeaple Probe) and thermal sensitivity (airblast/Schiff Air Index) evaluations of the selected test teeth were performed at baseline pre-treatment, and again at Weeks 2 and 8 of product use to compare the dentifrices' relative hypersensitivity protection effectiveness. RESULTS: Ninety-seven (97) of the 100 enrolled subjects completed the trial and were fully evaluable. At both Week 2 and Week 8, for both the thermal and tactile evaluation measurements, subjects brushing with the marketed SnF2 dentifrice experienced statistically significantly (p < 0.0001) superior average dentinal hypersensitivity improvement versus subjects assigned to the NaF/triclosan control dentifrice. Between groups, superior relative mean reduction in thermal Schiff Air Index favored SnF2 by 24% at Week 2 and 68% at Week 8, while greater relative mean tactile Yeaple Probe benefits were observed for SnF2 relative to the control by 114% after Week 2 and 184% at Week 8. The dentifrices were well-tolerated. CONCLUSION: Twice-daily brushing with a marketed SnF2 dentifrice provided superior dentinal hypersensitivity improvement versus a commercially available NaF/triclosan dentifrice, with significantly (p < 0.0001) greater relief after two weeks, and even larger relative benefits at eight weeks.

Digital plaque imaging evaluation of a stabilized stannous fluoride dentifrice compared with a triclosan/copolymer dentifrice.

PURPOSE: To compare the relative plaque control efficacy of a marketed 0.454% stabilized stannous fluoride (SnF2) dentifrice relative to a triclosan/copolymer dentifrice using digital plaque imaging analysis (DPIA). METHODS: This was a randomized, two-treatment, double-blind, parallel group design study that compared SnF2 and triclosan/copolymer dentifrices over a period of 3 weeks. DPIA was used to capture a digital image of the maxillary and mandibular anterior facial surfaces of 12 teeth and to calculate plaque area coverage. Overnight DPIA images were taken at a baseline visit after which subjects were randomly assigned to one of the two treatment groups and were required to brush with their assigned dentifrice according to each manufacturer's instructions. Subjects had DPIA assessments on two separate days at the end of Week 3. RESULTS: 96 subjects were randomized to treatment. Plaque area data for 47 subjects per treatment group were compared at Week 3 using ANCOVA. The SnF2 group demonstrated a statistically significant reduction in overnight plaque at Week 3 compared to baseline (P= 0.002). The reduction for the triclosan group at Week 3 compared to baseline was not statistically significant (P= 0.24). At Week 3, the SnF2 group demonstrated a 17% lower adjusted mean for overnight plaque relative to the triclosan group with a mean difference that was statistically significant (P< 0.05). The Week 3 adjusted mean change from baseline in overnight plaque for the SnF2 group was 3 times greater versus that of the triclosan group (P< 0.05).

8-week evaluation of anti-plaque and anti-gingivitis benefits of a unique multi-directional power toothbrush versus a sonic control toothbrush.

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 evaluable 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 < or = 0.003). Both toothbrushes were well-tolerated.

12-week clinical evaluation of a rotation/oscillation power toothbrush versus a new sonic power toothbrush in reducing gingivitis and plaque.

PURPOSE: To evaluate the efficacy of an advanced rotation/oscillation power toothbrush (Oral-B Triumph with SmartGuide) relative to a new sonic power toothbrush (Sonicare DiamondClean) in the reduction of gingivitis and plaque over a period of 12 weeks. METHODS: This was a single-center, open-label, examiner-blind, two-treatment, parallel group, randomized study in which subjects brushed with their assigned toothbrush and a marketed dentifrice for 2 minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at baseline, Week 6 and Week 12 using the Modified Gingival Index (MGI), Number of Bleeding Sites, and Rustogi Modification of the Navy Plaque Index (RMNPI). Safety was also assessed at every visit. At the end of the study, subjects completed a consumer questionnaire to evaluate their brushing experience. RESULTS: In total, 130 subjects were randomized to treatment and completed the study (65 per group). The rotation/oscillation group had higher gingivitis reductions from baseline at Weeks 6 and 12 by 31.9% and 32.3%, respectively, for MGI and by 43.4% and 34.9%, respectively, for number of bleeding sites than the sonic group. Group differences at both Weeks 6 and 12 were highly significant (P < 0.001) for both MGI and number of bleeding sites. The rotation/oscillation group had higher RMNPI plaque reductions from baseline at Weeks 6 and 12 by 15.8% and 19.3%, respectively, for whole mouth; by 24.1% and 30.4% at the gumline; and by 22.9% and 24.4% in the approximal regions, than the sonic group. Comparisons between groups at Week 12 were highly significant (P < or = 0.002) for all three mouth areas; group differences at Week 6 were significant (P < 0.05) for whole mouth and approximal RMNPI. Analysis of the questionnaire data showed that subjects using the rotation/oscillation brush rated it higher for several key attributes than subjects in the sonic group. There were no safety concerns with either brush.

Anti-gingivitis effects of a novel 0.454% stabilized stannous fluoride dentifrice relative to a positive control.

PURPOSE: To compare the anti-gingivitis efficacy of a novel 0.454% stannous fluoride dentifrice to a commercially available positive control triclosan-containing dentifrice in a population of adults with gingivitis. METHODS: This single-center, randomized and controlled, double-blind, parallel group, 2-month trial enrolled 200 adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis levels were assessed with both the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Subjects were randomly assigned to one of two test dentifrices: either 0.454% highly bioavailable stannous fluoride or the 0.30% triclosan positive control. Following at-home, unsupervised toothbrushing according to manufacturer's instructions with their assigned test dentifrice for 2 months, subjects were re-evaluated for gingivitis again via the MGI and GBI examinations. RESULTS: A total of 196 subjects completed the trial and were evaluable. At Month 2, both test dentifrices produced statistically significant reductions in number of bleeding sites, GBI, and MGI on average relative to pre-treatment (P< 0.0001). The Month 2 adjusted mean improvement from baseline for the stannous fluoride dentifrice group was 62% greater for number of bleeding sites, 60% greater for GBI, and 45% greater for MGI versus the triclosan/copolymer positive control group; groups differed significantly (P<0.0001) for each gingivitis measure at Month 2. Both dentifrices were well-tolerated.

Rapid desensitizing efficacy of a stannous-containing sodium fluoride dentifrice.

OBJECTIVE: To evaluate the efficacy of an experimental stannous-containing sodium fluoride dentifrice (1450 ppm fluoride) in the reduction of dentinal hypersensitivity over a three-day period as compared to a positive control dentifrice containing 8% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate. METHODS: This study, conducted in China, had a controlled, randomized, examiner-blind, two-treatment, parallel-group design. Eighy-one healthy adult subjects with moderate dentinal hypersensitivity were enrolled, two bicuspid or cuspid teeth in different quadrants demonstrating reproducible thermal (cold air) sensitivity with a score of > 1 on the SchiffAir Sensitivity Scale were chosen for each subject. Subjects also assessed their own level of pain on a Visual Analog Scale (VAS). Subjects were randomized to treatment with either the experimental or positive control dentifrice. At the baseline visit, sensitivity to thermal stimuli was assessed by both the examiner (Schiff Air Sensitivity) and the subject (pain VAS), and subjects were instructed to brush with their assigned study dentifrice according to the manufacturer's instructions provided. Immediately after brushing, thermal sensitivity for each enrolled tooth was reassessed by both examiner and subject. Subjects used their assigned dentifrices at home for three days, after which thermal sensitivity was reassessed by both examiner and subject. Subjects received an oral soft tissue examination at baseline and on Day 3. RESULTS: Forty subjects in the experimental group and 41 subjects in the positive control group completed all study procedures. On the Schiff Air Sensitivity Scale, the experimental dentifrice provided statistically significant (p < 0.001) reductions of 14.8% and 54.1% in sensitivity relative to the positive control dentifrice immediately after first use and at Day 3, respectively. On the pain VAS, the experimental dentifrice provided statistically significant (p < 0.001) reductions of 22.3% and 74.1% in sensitivity relative to the positive control dentifrice immediately after first use and at Day 3, respectively. No adverse events were reported for any subject. CONCLUSION: An experimental stannous-containing sodium fluoride dentifrice provided significantly better dentin hypersensitivity relief relative to a positive control dentifrice both immediately and after three days of product use.

Clinical evaluation of the fast onset and sustained sensitivity relief of a 0.454% stannous fluoride dentifrice compared to an 8.0% arginine-calcium carbonate-sodium monofluorophosphate dentifrice.

PURPOSE: To evaluate the efficacy of a dentifrice containing 0.454% stannous fluoride (SnF2) in the reduction of dentin hypersensitivity immediately after use, after 3 days and after a 2-week use period as compared to a positive control dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride as sodium monofluorophosphate. METHODS: 80 healthy adult subjects with moderate dentin hypersensitivity were enrolled in this clinical study, which had a controlled, randomized, examiner-blind, two-treatment (40 subjects per treatment group), parallel group design. For each subject, two sensitive bicuspid or cuspid teeth in different quadrants demonstrating reproducible sensitivity to thermal stimuli (Schiff air sensitivity score of > 1) were chosen for evaluation. Subjects were randomized to treatment with either the SnF2 dentifrice or the positive control dentifrice. At the baseline visit, subjects were assessed for sensitivity to thermal stimuli, received an oral soft tissue examination, and were instructed to brush with their assigned dentifrice according to manufacturers' usage instructions. Immediately after brushing, sensitivity to thermal stimuli for each enrolled tooth was assessed by an experienced dental examiner using the Schiff air sensitivity index and by study subjects based on air visual analog scale (VAS). After using their assigned dentifrice for 3 days and for 2 weeks, thermal sensitivity was re-assessed by both examiner and subject, and each subject received an oral soft tissue examination. RESULTS: 40 subjects in the SnF2 dentifrice group and 38 subjects in the control group completed all study procedures. Both dentifrice groups showed significant sensitivity relief relative to baseline (P < 0.01). The SnF2 dentifrice provided a statistically significant (P = 0.005) 7.4% reduction in sensitivity relative to the positive control dentifrice immediately after first use and an even more significant (P = 0.001) 20% reduction at Week 2 based on the Schiff air sensitivity scale. Based on the VAS, the SnF2 dentifrice provided statistically significant (P < 0.0001) reduction in sensitivity relative to the positive control dentifrice immediately after first use, at Day 3, and Week 2, with percent reductions of 7.2%, 15.8% and 28.2%, respectively. No adverse events were reported with either dentifrice.

Benefit of the power component of sonic and rotation-oscillation modes of action for plaque removal using power toothbrushes.

PURPOSE: To assess the benefit of the power component of two power toothbrushes, with sonic and rotation-oscillation mechanisms, on plaque removal efficacy. METHODS: Two independent studies with identical designs were used to assess the benefit of the power component of two power toothbrushes, with sonic and rotation-oscillation mechanisms, on plaque removal efficacy. Each brush was tested with the power 'On' relative to a control of the same brush with the power 'Off' used like a manual toothbrush. The studies were carried out independently at different sites, and each employed a replicate use, single brushing, two-treatment, four-period, examiner-blind, randomized, crossover design for assessing plaque removal. Study 1 compared rotation-oscillation action (Oral-B Triumph with FlossAction brush head), and Study 2 compared sonic action (Sonicare FlexCare with ProResults standard brush head) with power on versus off. The two treatments in each study consisted of (1) brushing teeth per manufacturer's instructions of the power toothbrush and (2) brushing without power by using the power toothbrush like a manual toothbrush. Prior to the treatment phase of each study, subjects exclusively used the assigned study toothbrush for 2 minutes twice per day according to the manufacturer's instructions (power on) during an acclimation period. Plaque was scored at prebrushing (baseline) and post-brushing on Visits 2, 3, 4 and 5 using the Turesky Modified Quigley-Hein Plaque Index (TMQHPI). A 2-day washout period separated each treatment period. RESULTS: 32 subjects were enrolled in each study; 28 subjects provided complete data for Study 1 and 32 subjects provided complete data for Study 2. The adjusted mean TMQHPI plaque removal scores for Study 1 were 0.793 for the rotation-oscillation 'On' regimen and 0.675 for the rotation-oscillation 'Off' regimen. This represents a statistically significantly (P<0.0001) greater plaque score reduction for the rotation-oscillation 'On' versus rotation-oscillation 'Off' treatment. The adjusted mean TMQHPI plaque removal scores for Study 2 were 1.042 for the sonic 'On' regimen and 1.007 for the sonic 'Off' regimen. This represents a nonsignificant (P=0.426) greater plaque score reduction for the difference between sonic 'On' versus sonic 'Off' regimen.

Innovations in global dentifrice technology: an advanced stannous-containing sodium fluoride dentifrice.

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.

Plaque and gingivitis reduction efficacy of an advanced pulsonic toothbrush: a 4-week randomized and controlled clinical trial.

PURPOSE: To compare the safety and efficacy of a novel sonic power toothbrush and a manual toothbrush in the reduction of gingivitis and plaque over a 4-week period. METHODS: This study employed a randomized two treatment, examiner-blinded, parallel group design. Subjects with evidence of gingivitis were randomly assigned to 4 weeks' twice daily home use of either the Oral-B Pulsonic sonic toothbrush or an ADA reference manual toothbrush. At baseline (Visit 1) and again after product use at Week 4, subjects received gingivitis evaluations with the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) examinations, followed by plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI). For 12 hours before both visits, subjects abstained from all oral hygiene, and ceased eating, drinking and smoking 4 hours prior. RESULTS: Both brushes significantly reduced gingivitis, gingival bleeding and plaque compared with baseline, and were well-tolerated by the 129 subjects completing the study. The sonic toothbrush was statistically significantly (P < 0.0001) more effective than the manual brush, with greater relative mean reductions in MGI, GBI and RMNPI of 11.9%, 62.3% and 46.5%, respectively.

Gingival transcriptome patterns during induction and resolution of experimental gingivitis in humans.

BACKGROUND: To our knowledge, changes in the patterns of whole-transcriptome gene expression that occur during the induction and resolution of experimental gingivitis in humans were not previously explored using bioinformatic tools. METHODS: Gingival biopsy samples collected from 14 subjects during a 28-day stent-induced experimental gingivitis model, followed by treatment, and resolution at days 28 through 35 were analyzed using gene-expression arrays. Biopsy samples were collected at different sites within each subject at baseline (day 0), at the peak of gingivitis (day 28), and at resolution (day 35) and processed using whole-transcriptome gene-expression arrays. Gene-expression data were analyzed to identify biologic themes and pathways associated with changes in gene-expression profiles that occur during the induction and resolution of experimental gingivitis using bioinformatic tools. RESULTS: During disease induction and resolution, the dominant expression pathway was the immune response, with 131 immune response genes significantly up- or downregulated during induction, during resolution, or during both at P <0.05. During induction, there was significant transient increase in the expression of inflammatory and oxidative stress mediators, including interleukin (IL)-1 alpha (IL1A), IL-1 beta (IL1B), IL8, RANTES, colony stimulating factor 3 (CSF3), and superoxide dismutase 2 (SOD2), and a decreased expression of IP10, interferon inducible T-cell alpha chemoattractant (ITAC), matrix metalloproteinase 10 (MMP10), and beta 4 defensin (DEFB4). These genes reversed expression patterns upon resolution in parallel with the reversal of gingival inflammation. CONCLUSIONS: A relatively small subset (11.9%) of the immune response genes analyzed by array was transiently activated in response to biofilm overgrowth, suggesting a degree of specificity in the transcriptome-expression response. The fact that this same subset demonstrates a reversal in expression patterns during clinical resolution implicates these genes as being critical for maintaining tissue homeostasis at the biofilm-gingival interface. In addition to the immune response pathway as the dominant response theme, new candidate genes and pathways were identified as being selectively modulated in experimental gingivitis, including neural processes, epithelial defenses, angiogenesis, and wound healing.

Clinical assessment of extrinsic stain removal efficacy with a new Pulsonic toothbrush.

OBJECTIVE: To assess the extrinsic stain removal benefit of two different power toothbrushes: an experimental Oral-B Pulsonic rechargeable toothbrush and a positive control Sonicare FlexCare toothbrush. METHODS: This was a randomized, positive-controlled, examiner-blind, two-treatment, parallel group, two-week study. A Lobene stain index was performed at baseline on the facial surfaces of the anterior teeth. Subjects were randomized to one of two treatment groups: Pulsonic or FlexCare. Both groups were assigned the same fluoride dentifrice, and were instructed to brush their teeth twice per day for two minutes with the assigned toothbrush and dentifrice in front of a mirror. A further Lobene stain index was performed following two weeks of brushing. RESULTS: A highly significant reduction (p < 0.001) in mean Lobene composite scores after two weeks was found for both the Pulsonic treatment group and the FlexCare treatment group (median reduction of 94.4% and 90.7%, respectively). Both treatment groups also showed a highly significant (p < 0.001) reduction in extent and intensity scores. No significant treatment group differences were seen in the reduction in mean Lobene scores (p > 0.1). CONCLUSION: Both the experimental Pulsonic and the positive control FlexCare power toothbrushes showed highly effective stain removal efficacy relative to baseline following two weeks of brushing. Stain removal efficacy did not differ significantly between brushes.

A randomized 12-week study to compare the gingivitis and plaque reduction benefits of a rotation-oscillation power toothbrush and a sonic power toothbrush.

OBJECTIVE: Sonic and rotation-oscillation power toothbrushes are popular and effective, but have been shown to differ in relative benefits. The objective of this 12-week investigation was to compare the efficacy of a rotation-oscillation powered toothbrush and a newly introduced sonic toothbrush in the reduction of gingivitis and dental plaque. METHODS: This was a randomized, controlled, examiner-blind, two-treatment, parallel-group study to assess gingivitis reduction and plaque reductions after twice-daily brushing with either the rotation-oscillation brush or the sonic toothbrush over 12 weeks. The Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) were used to determine gingivitis benefits at Week 6 and Week 12, and plaque was scored at these visits before and after supervised brushing using the Rustogi Modified Navy Plaque Index (RMNPI). RESULTS: In 171 evaluable subjects, gingivitis reduction benefits were significantly greater for the rotation-oscillation brush group than for those using the sonic toothbrush, with relative mean benefits favoring the rotation-oscillation brush of 29.4% for GBI and 8.2% for MGI at 12 weeks (p < or = 0.01). The rotation-oscillation brush produced significantly lower RMNPI plaque by 33.3% compared to the sonic toothbrush (p < 0.001) at Week 12. CONCLUSION: The rotation-oscillation power toothbrush was significantly more efficacious than the sonic toothbrush in removing plaque, in reducing gingivitis, and lowering the number of bleeding sites after 12 weeks of twice-daily brushing.

Replicate single-use comparative study of plaque removal with two contemporary manual toothbrushes.

PURPOSE: To compare the plaque removing efficacy of Oral-B Advantage 123 and Colgate 360 degrees manual toothbrushes on a single brushing after a 24-hour void in oral hygiene. METHODS: This study had a two-treatment (Advantage 123 versus Colgate 360 degrees), examiner-blind, randomized, four-period (visit) crossover design. At the first (baseline) visit, subjects received a plaque examination using the Rustogi Modified Navy Plaque Index (RMNPI) after which they were instructed to brush for 1 minute in their normal manner with their assigned toothbrush and a marketed dentifrice and unaided by access to a mirror. Post-brushing plaque was then assessed. At three further visits, each separated by a period of 3-8 days, brushes were assigned to subjects according to their treatment sequence and the same brushing and plaque grading procedure as at baseline was followed. RESULTS: 50 subjects were enrolled in the replicate single-use study; all were included in the analysis. Oral-B Advantage 123 was significantly better than Colgate 360 degrees at reducing whole mouth (P = 0.006), gingival margin (P = 0.010) and approximal (P = 0.040) plaque scores.