A clinical study to assess the gingivitis reduction efficacy of a novel stannous-containing fluoride dentifrice.

PURPOSE: To assess the gingivitis reduction efficacy of a novel stannous-containing fluoride dentifrice relative to a negative control. METHODS: 100 generally healthy adults with 10 or more gingival bleeding sites based on the Mazza Modification of the Papillary Bleeding Index (Mazza GI) were enrolled into a 2-week randomized, controlled, double-blind, single-center, two-treatment, parallel group clinical study. The subjects were randomly assigned to the stannous-containing dentifrice group (experimental group) or the sodium fluoride dentifrice group (negative control group). An oral examination and Mazza GI examination were conducted at Baseline, Day 3 and Week 2 post-baseline by a qualified dental examiner. RESULTS: 98 subjects completed the study. The experimental group provided a significant reduction in Mazza GI scores and number of bleeding sites relative to baseline at Day 3 and Week 2 (P< 0.0001). The negative control did not provide significant reductions versus baseline for either measure at either timepoint (P> 0.3). At Day 3, the experimental group provided a statistically significant reduction of Mazza GI scores and number of bleeding sites compared with the negative control group (P< 0.0001). At Week 2, the experimental group showed 24.11% lower Mazza GI scores and 54.81% fewer bleeding sites than the negative control group (P< 0.0001). CLINICAL SIGNIFICANCE: The results demonstrated that the novel stannous-containing fluoride dentifrice had a superior anti-gingivitis effect compared to the sodium fluoride negative control dentifrice, which was evident as quickly as 3 days after use and further improved after 2 weeks of usage.

A randomized 3-month clinical comparison of a power toothbrush to a manual toothbrush in the reduction of gingivitis.

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. CLINICAL SIGNIFICANCE: The power brush provided statistically significantly greater reductions in gingivitis compared with a manual toothbrush at Months 1, 2 and 3.

Two-week extrinsic stain removal efficacy of a sodium fluoride dentifrice with high cleaning silica: results from two randomized, controlled clinical trials.

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 brush 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).

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.

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.

The anti-plaque efficacy of a novel stannous-containing sodium fluoride dentifrice: a randomized and controlled clinical trial.

PURPOSE: To evaluate the anti-plaque efficacy of a novel stannous-containing sodium fluoride dentifrice compared to a negative control regular anti-caries dentifrice and a positive control marketed triclosan-containing dentifrice. METHODS: This was a randomized and controlled, single-center, double-blind, three-treatment, three-period, crossover clinical trial in generally healthy adults. A prophylaxis was followed by three 4-day treatment periods of limited brushing, each separated by an approximate 7-day washout phase. Subjects used the test dentifrice on Days 0-3 of each period according to their randomly assigned sequence; either Crest Cavity Protection (negative control); an experimental stannous-containing sodium fluoride dentifrice; or a marketed triclosan positive control (Colgate Total). A dental polishing was given at Day 0 of each treatment period, and subjects brushed the lingual surfaces only and then swished the entire dentition with a dentifrice slurry twice daily under supervision through Day 3. At baseline and Day 4 of each treatment period, plaque levels were assessed via the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). RESULTS: Twenty-eight fully evaluable subjects completed the trial. Both the experimental and positive control dentifrices provided significantly lower mean whole mouth TMQHPI plaque scores after treatment compared to the negative control: 11.4% lower for the experimental stannous-containing dentifrice and 8.4% for Colgate Total (P< 0.0001). The experimental stannous-containing dentifrice group resulted in directionally lower whole mouth plaque scores when compared to Colgate Total (P= 0.07). The experimental stannous-containing dentifrice had significantly lower mean plaque scores post-treatment at lingual sites compared with Total (P= 0.0355). All dentifrices were well-tolerated.

A randomized cross-over clinical trial to evaluate the effect of a 0.454% stannous fluoride dentifrice on the reduction of oral malodor.

PURPOSES: To compare the oral malodor protection efficacy of a 0.454% stannous fluoride dentifrice versus a negative control (0.243% sodium fluoride) using a sulfide monitor (halimeter) as the measurement. A secondary objective was to assess the effects of tongue brushing. METHODS: This was a four-treatment, five-period, examiner-blinded, crossover, randomized study. Healthy subjects who met the entrance criteria were enrolled into the study. A 5-day acclimation period, in which subjects brushed twice daily in their customary manner with a standard sodium fluoride dentifrice, occurred prior to baseline. After baseline halimeter measurements, subjects were randomly assigned to one of four treatments (SnF2 dentifrice groups, with or without tongue brushing; negative control dentifrice groups, with or without tongue brushing) based on baseline halimeter scores, age, and gender. Test products were used three times a day. Breath measurements were taken 24 hours after baseline (after three product uses). Subjects then brushed again with the product treatment. Final breath measurements were taken 4 hours later, 28 hours after baseline. A 5-day washout separated each treatment period. RESULTS: 33 subjects were enrolled and completed the study. The adjusted mean volatile sulfur compound (VSC) levels were significantly lower in the SnF2 groups than the NaF groups, at both 24 (P < 0.01) and 28 (P < 0.001) hours post baseline time points. Tongue brushing did not provide additional statistically significant breath benefits when compared to toothbrushing alone. Both dentifrices were well tolerated.

The desensitizing efficacy of a novel stannous-containing sodium fluoride dentifrice: an 8-week randomized and controlled clinical trial.

PURPOSE: To assess the efficacy of a novel stannous-containing dentifrice in the reduction of dentin hypersensitivity when compared to a marketed positive control dentifrice. METHODS: An 8-week, single-center, randomized, parallel group, two-treatment, double-blind clinical study was conducted in a generally healthy adult population with moderate thermal and tactile dentin hypersensitivity. A total of 60 adults were enrolled into the study. Participants were stratified at baseline by age, gender, and cold air sensitivity scores, and randomly assigned to either an experimental stannous-containing sodium fluoride dentifrice or a marketed potassium nitrate positive control. Brushing was supervised on site after baseline and Week 4 examinations. All other product usage was unsupervised. Subjects brushed 2 minutes twice daily. At baseline, Week 4 and Week 8, efficacy outcomes were assessed for tactile sensitivity via the Yeaple Probe, and for thermal sensitivity with air-blast/SchiffAir Index. RESULTS: Fifty-eight subjects completed all evaluations. Both the experimental stannous-containing and positive control dentifrices provided significant (P< 0.05) reductions in both tactile and thermal dentin hypersensitivity compared to baseline at both Weeks 4 and 8. There were no significant differences in Yeaple Probe or Schiff Air Index results between the dentifrices with either efficacy measurement at Week 4 and Week 8 (P > or = 0.5375).

Breath malodor reduction with use of a stannous-containing sodium fluoride dentifrice: a meta-analysis of four randomized and controlled clinical trials.

PURPOSE: To determine the effectiveness of a novel stannous-containing sodium fluoride dentifrice in reducing malodor-causing volatile sulfur compound (VSC) levels versus a standard marketed fluoride (negative control) anti-caries dentifrice using pooled data from independent clinical trials. METHODS: Four randomized and controlled, evaluator-blinded, 3- or 4-period, 2-treatment crossover clinical studies were conducted at four separate centers in Asia and the United States in subjects with a baseline VSC score of > 100 ppb. Following a week-long acclimation period, subjects were randomly assigned to a treatment sequence specifying the order of use of a stannous-containing sodium fluoride dentifrice and a negative control dentifrice (Crest Cavity Protection). VSC levels were assessed at four time points using a Halimeter during each treatment period: (1) baseline prior to treatment; (2) 3-4 hours after baseline and a single brushing; (3) 24 hours post-baseline and after two total brushings ("overnight"/"morning breath"); and (4) 27-28 hours post-baseline following three total product uses. Brushing instructions were standardized and required two minutes of timed toothbrushing with the assigned dentifrice. Washout periods of at least 2 days separated the treatment periods. RESULTS: A total of 100 subjects were included in the meta-analysis. The stannous-containing dentifrice showed statistically significantly greater breath benefits via VSC reduction compared to the negative control dentifrice (P < 0.047) at all three time points. The stannous-containing dentifrice provided increasingly greater superior relative breath protection benefits of 7.7% at Hour 3-4 post-baseline, 10.6% after 24 hours ("overnight"/"morning breath"), and 24.5% at Hour 27-28. Similar malodor reduction benefits in favor of the stannous-containing dentifrice relative to the negative control were observed for each individual study.

Clinical comparison of the plaque removal efficacy of a manual toothbrush with criss-cross bristle design.

PURPOSE: To compare the plaque removal efficacy of two manual toothbrushes: Oral-B Exceed and Asian Colgate 36 degrees manual toothbrush. METHODS: The study used an examiner-blind, two-treatment, randomized, four-period (visits) crossover design. Subjects used each brush twice during the study. At the first visit, 41 subjects who met inclusion criteria and provided informed consent received a baseline plaque examination using the Turesky Modified Quigley-Hein Plaque Index. Subjects then used their assigned toothbrush for 1 minute with a marketed toothpaste without access to a mirror. Brushing was monitored. A post-brushing plaque exam was then performed. Subjects were rescheduled for their next visit in approximately 3 days. At visits 2, 3 and 4 the same disclosing, brushing and plaque grading procedures were followed. Subjects used their own products at home between visits. RESULTS: 39 subjects presented data for all four study periods; two subjects missed one period each. Baseline plaque scores were balanced between the two groups. Adjusted mean plaque removal (baseline minus post-brushing) scores were 0.479 for the Exceed toothbrush and 0.425 for the Asian Colgate 360 degrees toothbrush (P < 0.002). This translates to 12.7% greater plaque removal for the Exceed toothbrush versus the Asian Colgate 360 degrees toothbrush. No adverse events were reported during the study.