A clinical study to measure anti-erosion properties of a stabilized stannous fluoride dentifrice relative to a sodium fluoride/triclosan dentifrice.

OBJECTIVE: To compare the enamel protection efficacy of a stabilized stannous fluoride (SnF2 ) dentifrice to a sodium fluoride (NaF)/triclosan dentifrice following acidic erosive challenge. METHODS: In this in situ, randomized, controlled, double-blind, two-treatment, four-period crossover clinical trial, subjects wore an appliance fitted with human enamel samples 6 h day-1 during each 15-day treatment period. Twice each treatment day they swished with their assigned dentifrice slurry: 0.454% SnF2 /0.077% NaF or 0.32% NaF/0.3% triclosan. After each treatment and two other times daily, subjects swished with 250 ml of orange juice over a 10-min period (acidic erosive challenge). Enamel samples were measured for tooth surface loss using contact profilometry at baseline and days 10 and 15. RESULTS: Thirty-six subjects (mean age 44.8 years, range 23-65 years) were randomized to treatment; 33 subjects completed the final study visit. There were no statistically significant baseline differences (P > 0.44) in the specimen surfaces of the two dentifrice treatment groups via profilometry. At day 10, the SnF2 dentifrice provided a statistically significant (P < 0.0001) reduction in enamel loss by 67% versus the NaF/triclosan dentifrice with estimated medians of 1.22 and 3.68 µm, respectively. At day 15, the SnF2 dentifrice again provided a significantly greater benefit (P < 0.0001) against tooth surface loss versus the NaF/triclosan dentifrice, with 68% less erosion, and estimated medians of 1.60 and 5.03 µm, respectively. Both dentifrices were well tolerated. CONCLUSION: A stabilized SnF2 dentifrice provided superior protection against the initiation and progression of tooth enamel surface loss in situ after erosive challenge compared to a NaF/triclosan dentifrice.

Erosion protection benefits of stabilized SnF2 dentifrice versus an arginine-sodium monofluorophosphate dentifrice: results from in vitro and in situ clinical studies.

OBJECTIVES: The aim of these investigations was to assess the ability of two fluoride dentifrices to protect against the initiation and progression of dental erosion using a predictive in vitro erosion cycling model and a human in situ erosion prevention clinical trial for verification of effectiveness. MATERIALS AND METHODS: A stabilized stannous fluoride (SnF2) dentifrice (0.454 % SnF2 + 0.077 % sodium fluoride [NaF]; total F = 1450 ppm F) [dentifrice A] and a sodium monofluorophosphate [SMFP]/arginine dentifrice (1.1 % SMFP + 1.5 % arginine; total F = 1450 ppm F) [dentifrice B] were tested in a 5-day in vitro erosion cycling model and a 10-day randomized, controlled, double-blind, two-treatment, four-period crossover in situ clinical trial. In each study, human enamel specimens were exposed to repetitive product treatments using a standardized dilution of test products followed by erosive acid challenges in a systematic fashion. RESULTS: Both studies demonstrated statistically significant differences between the two products, with dentifrice A providing significantly better enamel protection in each study. In vitro, dentifrice A provided a 75.8 % benefit over dentifrice B (p < 0.05, ANOVA), while after 10 days in the in situ model, dentifrice A provided 93.9 % greater protection versus dentifrice B (p < 0.0001, general linear mixed model). CONCLUSION: These results support the superiority of stabilized SnF2 dentifrices for protecting human teeth against the initiation and progression of dental erosion. CLINICAL RELEVANCE: Stabilized SnF2 dentifrices may provide more significant benefits to consumers than conventional fluoride dentifrices.

A randomized clinical study to assess ingestion of dentifrice by children.

This study investigated whether there was a difference in amounts of dentifrice ingested by children based on age using pea-sized instructions. The study had a randomized, single-blinded, 3-period, crossover design modelled after Barnhart et al. (1974) with one regular-flavored and two specially-flavored dentifrices used ad libitum. Subjects were enrolled in three groups: 2-4, 5-7, and 8-12 years. They were instructed to brush at home as they would normally with each dentifrice for 3 weeks (9 weeks total). On weekly study-site visits, subjects brushed with the assigned dentifrice containing a lithium marker to measure the amount of dentifrice ingested and used. Averaging across dentifrices, amounts ingested were: 0.205 g (2-4 yr), 0.125 g (5-7 yr) and 0.135 g (8-12 yr), demonstrating 2-4 year-olds ingested significantly more than older children (p ≤ 0.002). Averaging across dentifrices, amounts used were: 0.524 g (2-4 yr), 0.741 g (5-7 yr) and 0.978 g (8-12 yr) suggesting an age-related effect (p < 0.01). Findings also showed that ingestion amount for specially-flavored dentifrices may increase relative to regular-flavored dentifrice for children 2-7 years-old. This research demonstrated that dentifrice ingestion amount decreased significantly with age while usage amount increased with age. Importantly, ingestion and usage levels in younger children reflect "pea-sized" direction and were numerically lower than historical levels reported prior to this direction.

Randomized in vivo trial evaluating plaque inhibition benefits of an advanced stannous-containing sodium fluoride dentifrice used in conjunction with power brush technology.

OBJECTIVE: To compare the plaque inhibition efficacy of a novel stannous-containing sodium fluoride test dentifrice to a standard anticavity negative control dentifrice, when both were used in conjunction with an advanced oscillating-rotating (O/R) power toothbrush. METHODS: This was a randomized, two-treatment, three-period, double-blind crossover study conducted in a population using an O/R power brush. Subjects brushed twice per day with their assigned dentifrice during the three-treatment periods, each lasting for 17 consecutive days. Each period was separated by a 4-day washout period during which subjects continued to use their O/R power toothbrush. Plaque levels were assessed and averaged amongst three assessments taken on days 15, 16 and 17 at the end of each treatment period using digital plaque imaging analysis. Assessments were carried out on the facial anterior tooth surfaces in the morning before brushing (A.M. prebrush) following whole-mouth brushing (30 s per quadrant) with the assigned dentifrice (A.M. post-brush) and in the afternoon (P.M.). RESULTS: Twenty-seven subjects were randomized and completed the study. During the 17-day usage period, the stannous-containing test NaF dentifrice demonstrated a statistically significant lower mean plaque area versus the negative control dentifrice at each assessment timepoint; overnight A.M. prebrush was 33.8% lower (P < 0.0001), A.M. post-brush was 21.8% lower (P < 0.01), and P.M. was 29.2% lower (P < 0.0001). CONCLUSION: A population of O/R power toothbrush users had significantly less plaque coverage for all three measurements when using a stannous-containing NaF dentifrice than when using a negative control (fluoride) dentifrice.

Plaque control evaluation of a stabilized stannous fluoride dentifrice compared to a triclosan dentifrice in a six-week trial.

OBJECTIVE: To compare the anti-plaque efficacy of a stabilized 0.454% stannous fluoride (referred to as SnF2) dentifrice versus a 0.3% triclosan dentifrice formulated with a copolymer and sodium fluoride (referred to as triclosan). METHODS: The study had a randomized, double-blind, two-treatment, parallel-group design, and compared plaque reduction from baseline after both three and six weeks of treatment with either the SnF2 or triclosan dentifrices using a manual toothbrush. Subjects brushed their teeth using their assigned treatment dentifrices according to the manufacturer's instructions. Following overnight plaque accumulation, levels of plaque were assessed by an experienced examiner using the Rustogi, et al. Modified Navy Plaque Index at the start of the study (baseline), and after three and six weeks of regular brushing. Groups were compared using analysis of covariance separately for Weeks 3 and 6, and by repeated measures for Weeks 3 and 6 combined. RESULTS: One-hundred and twenty subjects were randomized to treatment and 114 subjects completed the study. Both treatment groups showed a statistically significant reduction from baseline in mean plaque values for all three tooth areas (whole mouth, gingival margin, interproximal) at both Weeks 3 and 6 (p < 0.02 for all comparisons). Analysis of covariance showed a statistically significantly (p < 0.0001) lower adjusted mean plaque level for the SnF2 group compared to the triclosan group for all three tooth areas at both Weeks 3 and 6, and for Weeks 3 and 6 combined. Weeks 3 and 6 combined adjusted mean plaque was 36.5% lower for whole mouth for the SnF2 group versus the triclosan group. Weeks 3 and 6 combined adjusted mean plaque reduction from baseline was three times greater for the SnF2 group relative to the triclosan group. CONCLUSION: Both dentifrices showed statistically significant reductions from baseline in whole mouth, gumline, and interproximal accumulated overnight plaque after three and six weeks of brushing, but the SnF2 dentifrice showed statistically significantly greater plaque reductions versus the triclosan dentifrice.

In vitro comparison of stannous fluoride, sodium fluoride, and sodium monofluorophosphate dentifrices in the prevention of enamel erosion.

OBJECTIVE: To compare the relative performance of commercially available dentifrices containing different types of fluoride to reduce enamel erosion from citric acid. METHODS: Two randomized parallel-group experiments were conducted, each with 48 bovine enamel samples randomly divided into six treatment legs. Each treatment leg went through 24 toothpaste treatment cycles, acid challenge (0.05M citric acid), and remineralization in artificial saliva. Total acid immersion after all cycles was 300 minutes for each test product; two test products in Experiment 1 were also evaluated for 180 minutes for comparison. Samples were analyzed blinded to treatment group for enamel loss by contact profilometry. One stabilized stannous fluoride (SnF2) dentifrice was compared to three sodium fluoride (NaF) dentifrices, two sodium monofluorophosphate (MFP) dentifrices, and one MFP plus calcium sodium phosphosilicate (CSP) dentifrice. All fluoride levels were 1450 ppm. A water control was also included. RESULTS: The dentifrice containing stabilized SnF2 was significantly (p < 0.0001) better at preventing enamel erosion compared to the NaF and MFP dentifrices. The SnF, dentifrice provided a 61.7% (p < 0.0001) reduction in enamel loss versus the water control. The comparable figures for NaF and MFP dentifrices were 36-39% (p < 0.0001) and 33% (p < 0.0001) reductions, respectively, compared to the water control. The MFP+CSP dentifrice was significantly (p < 0.05) less effective, providing a 23.2% (p = 0.0007) reduction versus the water control. CONCLUSION: Of the dentifrices included in this research, the stabilized SnF, dentifrice was the most effective at reducing enamel erosion from citric acid.

Randomized digital plaque imaging trial evaluating plaque inhibition efficacy of a novel stabilized stannous fluoride dentifrice compared with an amine fluoride/stannous fluoride dentifrice.

OBJECTIVE: To assess the plaque inhibition efficacy ofa novel 0.454% stabilized stannous fluoride test dentifrice (SnF2) to an amine fluoride/stannous fluoride marketed control dentifrice (AmF/SnF2) using digital plaque imaging analysis (DPIA). METHODS: The 10-week study was a randomized, two-treatment, three-period, double-blind crossover design. Subjects brushed twice daily with their assigned dentifrice (SnF2 or AmF/SnF2) using a standard manual toothbrush during three treatment periods each lasting 17 days, separated by four-day washout periods. DPIA was used to analyze plaque coverage on facial surfaces of the 12 anterior teeth (canine to canine) by three assessments on Days 15, 16, and 17 at the end of each treatment period. Assessments were conducted the morning following no overnight brushing of facial surfaces (A.M. pre-brush), after 40 seconds of full mouth brushing with the assigned dentifrice (A.M. post-brush), and during the afternoon (P.M.). RESULTS: Twenty-seven subjects were randomized and completed the study. At each assessment time point, plaque levels for the SnF2 dentifrice were statistically significantly lower compared to those for the AmF/SnF2 dentifrice (21.4%, 22.6%, 24.3%, respectively; p < 0.0001 for all). CONCLUSION: Plaque coverage, as assessed by DPIA, was significantly lower with a novel SnF2 dentifrice than with the AmF/SnF2 dentifrice. The plaque control benefits of the SnF2 dentifrice seen at the morning and afternoon time points indicated significantly better inhibition of plaque re-growth.

Fast onset sensitivity relief of a 0.454% stannous fluoride dentifrice.

OBJECTIVE: To evaluate the efficacy ofa stannous fluoride dentifrice as compared to a negative control dentifrice in the reduction of dentinal hypersensitivity after immediate use, and after three days and two weeks of use. METHODS: This was a controlled, randomized, examiner-blind, two-treatment, parallel group study conducted among healthy adult male and female subjects with moderate dentinal hypersensitivity. Subjects with at least two sensitive teeth demonstrating reproducible sensitivity to both thermal stimuli (SchiffAir Sensitivity Scale score of > 1) and tactile stimuli (Yeaple probe 10 grams) were randomized to treatment with either a 0.454% stannous fluoride (SnF,) dentifrice (experimental group) or a 0.76% sodium monofluorophosphate dentifrice (negative control group). At baseline, subjects received an oral soft tissue examination, were assessed for tooth sensitivity, and were instructed, according to manufacturer's product instructions, to brush with their assigned dentifrice thoroughly twice a day (morning and evening). Subjects performed their first product use on site under supervision. Immediately following the first treatment, both examiner and subject assessed sensitivity to thermal stimuli for each enrolled tooth using the Schiff Air Sensitivity Scale and air visual analog scale (VAS), respectively. Thermal sensitivity was also assessed (by both examiner and subject) at the Day 3 and Week 2 study visits, together with tactile sensitivity (Yeaple probe) and oral soft tissue exams of the mouth. RESULTS: One-hundred and eleven subjects were enrolled and randomized to one of the two treatment groups. Immediately after the first use, the SnF, dentifrice provided statistically significant (p < 0.0001) reductions in sensitivity relative to the negative control dentifrice of 13.8% for the thermal Schiff Air Sensitivity Scale and 14.6% for the air VAS. The SnF, dentifrice also provided statistically significant (p < 0.0001) reductions in sensitivity relative to the negative control at Day 3 and at Week 2 based on the thermal Schiff Air Sensitivity Scale (31.8% and 61.3%, respectively) and the thermal air VAS (34.8% and 66.6%, respectively). For the tactile Yeaple probe, the SnF2 dentifrice demonstrated significantly (p < 0.0001) better sensitivity scores relative to the negative control at Day 3 and Week 2, with improvements of 186% and 239%, respectively. Both dentifrices were well tolerated. CONCLUSION: An experimental 0.454% SnF2 dentifrice provides significantly better immediate and ongoing sensitivity relief relative to a negative control dentifrice.

Can anti-erosion dentifrices also provide effective plaque control?

OBJECTIVE: While gingivitis and caries continue to be prevalent issues, there is growing concern about dental erosion induced by dietary acids. An oral hygiene product that protects against all these conditions would be beneficial. This study investigated the potential of two anti-erosion dentifrices to inhibit plaque. METHODS: This was a randomized, three-period, two-treatment, double-blind, crossover study evaluating a stannous chloride/sodium fluoride dentifrice (SnCl(2)/NaF, blend-a-med(®) Pro Expert) and a popular anti-erosion dentifrice (NaF, Sensodyne(®) ProNamel(™)). During Period 3, subjects were randomized to repeat one treatment to evaluate any product carryover effects. Each treatment period was 17 days. Test dentifrices were used with a standard manual toothbrush. Digital plaque image analysis (DPIA) was employed at the end of each period to evaluate plaque levels (i) overnight (am prebrush); (ii) post-brushing with the test product (am post-brush); and (iii) mid-afternoon (pm). Analysis was conducted via an objective computer algorithm, which calculated total area of visible plaque. RESULTS: Twenty-seven subjects completed the study. At all time points, subjects had statistically significantly (P ≤ 0.0001) lower plaque levels after using the SnCl(2)/NaF dentifrice than the NaF dentifrice. The antiplaque benefit for the SnCl(2)/NaF dentifrice versus the NaF dentifrice was: am prebrush = 26.0%; am post-brushing = 27.9%; pm = 25.7%. CONCLUSIONS: The SnCl(2)/NaF dentifrice provided significantly greater daytime and overnight plaque inhibition than the NaF toothpaste. When recommending dentifrice to patients susceptible to dental erosion, clinicians can consider one that also inhibits plaque.

Clinical comparison of plaque inhibition effects of a novel stabilized stannous fluoride dentifrice and a chlorhexidine digluconate dentifrice using digital plaque imaging.

OBJECTIVE: To compare the plaque inhibition efficacy of a novel 0.454% stannous fluoride (SnF2) test dentifrice with sodium hexametaphosphate and stannous chloride to a chlorhexidine digluconate (0.05%), aluminium lactate (0.8%), and aluminium fluoride marketed control dentifrice (Lacalut Aktiv or AlF3/Chx). METHODS: This was a randomized, two-treatment, two-period, double-blind crossover study that compared the SnF2 test dentifrice to the AlF3/Chx control dentifrice. Each of the two treatment periods lasted for 17 consecutive days of product use, during which subjects were required to brush twice per day with their assigned dentifrice using a standard manual toothbrush (Oral-B P35 Indicator). The two periods of the crossover were separated by a four-day washout period. Plaque levels on the facial anterior tooth surfaces were evaluated and averaged among three assessment days at the end of each treatment period using digital plaque imaging analysis (DPIA). The evening prior to assessments, subjects only brushed lingual surfaces. Assessment time points were carried out in the morning following no morning brushing (A.M. pre-brush), following 40 seconds of brushing with the assigned dentifrice (A.M. post-brush), and in the afternoon (P.M.). The DPIA captured images were used to calculate and analyze visible plaque coverage. RESULTS: Twenty-eight subjects were randomized and completed the study. At each assessment time point, the SnF2 test dentifrice demonstrated a statistically significant lower plaque level compared to the AlF3/Chx dentifrice: A.M. mean pre-brush 15.9% lower, p < 0.05; A.M. mean post-brush 22.2% lower, p < 0.05; P.M. mean 24.3% lower, p < 0.005. CONCLUSION: Compared to the AlF3/Chx control dentifrice, the novel SnF2 test dentifrice significantly inhibited plaque regrowth overnight and during the day. Immediately after brushing there was also significantly less plaque coverage with the SnF2 test dentifrice.

Prevention of lingual calculus formation with daily use of 6% H2O2/2% pyrophosphate whitening strips.

OBJECTIVE: This randomized controlled clinical trial was conducted to evaluate whether daily use of a hydrogen peroxide/ pyrophosphate-containing antitartar whitening strip might safely yield clinical reductions in post-prophylaxis calculus accumulation. METHODS: A three-month, randomized controlled trial was conducted to compare calculus accumulation with a daily 6% hydrogen peroxide/pyrophosphate strip versus regular brushing. After an eight-week run-in phase to identify calculus formers, a prophylaxis was administered, and 77 subjects were randomly assigned to daily strip or brushing only groups. All subjects received an anticavity dentifrice (Crest Cavity Protection) and manual brush for use throughout the three-month study; for subjects assigned to the experimental group, strip application was once daily for five minutes on the facial and lingual surfaces of the mandibular teeth. Efficacy was measured as mm calculus (VMI) before prophylaxis and after six and 12 weeks of treatment, while safety was assessed from examination and interview. RESULTS: Subjects ranged in age from 21-87 years, with groups balanced (p > 0.26) on pertinent demographic and behavioral parameters, and pre-prophylaxis calculus baseline mean scores (16.0 mm). At Week 6, calculus accumulation was lower in the strip group, with adjusted mean (SE) lingual VMI of 12.0 (0.87) for the strip group and 17.0 (0.88) for the brushing control. At Week 12, calculus accumulation was lower in the strip group, with adjusted mean (SE) lingual VMI of 14.3 (0.85) for the strip group and 17.2 (0.86) for the brushing control. Treatments differed significantly (p < 0.02) on calculus accumulation at both time points. A total of three subjects (8%) in the strip group and two subjects (5%) in the brushing control had mild oral irritation or tooth sensitivity during treatment; no one discontinued early due to an adverse event. CONCLUSION: Daily use of hydrogen peroxide whitening strips with pyrophosphate reduced calculus formation by up to 29% versus regular brushing, without meaningful adverse events.

A randomized clinical study comparing the plaque inhibition effect of a SnF2/SHMP dentifrice (blend-a-med EXPERT GUMS PROTECTION) and a chlorhexidine digluconate dentifrice (Lacalut Aktiv).

OBJECTIVE: To compare the plaque inhibition benefits of a control 0.454% stannous fluoride/sodium hexametaphosphate/sodium fluoride dentifrice (SnF2/SHMP with 1450 ppm F) to a chlorhexidine digluconate (0.05%), aluminum lactate (0.8%), and aluminum fluoride (AlF3/Chx with 1400 ppm F) dentifrice. METHODS: Twenty-nine subjects were randomized to a two-period, two-treatment, double-blind crossover sequence using blend-a-med EXPERT GUMS PROTECTION toothpaste (SnF2/SHMP) and Lacalut Aktiv toothpaste (AlF3/Chx). Each treatment was used along with a standard manual toothbrush (Oral-B P35 Indicator) for 17 days. Digital plaque image analysis (DPIA) was used at the end of each period for three consecutive days to evaluate plaque levels; a) overnight (A.M. pre-brush); b) following 40 seconds of brushing with the test product (A.M. post-brush); and c) mid-afternoon (P.M.). Images were analyzed using an objective computer algorithm to calculate the total area of visible plaque. A four-day washout period was instituted for the crossover phase. RESULTS: Twenty-seven subjects completed the study. The SnF2/SHMP dentifrice provided a statistically significant lower level of plaque area coverage compared to the AlF3/Chx dentifrice at all time points. For the SnF2/SHMP dentifrice, plaque coverage was 19.4% lower (p = 0.0043) at the A.M. pre-brush, 25.6% lower (p = 0.0014) at the A.M. post-brush, and 19.8% lower (p = 0.0057) at the P.M. measure relative to the AlF3/Chx dentifrice. CONCLUSION: The blend-a-med EXPERT GUMS PROTECTION toothpaste inhibits plaque regrowth, both overnight and during the day, to a significantly greater degree than Lacalut Aktiv. Additionally, immediately after brushing with blend-a-med EXPERT GUMS PROTECTION, subjects had significantly less plaque than after brushing with Lacalut Aktiv.

Comparison of a stabilized stannous fluoride/sodium hexametaphosphate dentifrice and a zinc citrate dentifrice on plaque formation measured by digital plaque imaging (DPIA) with white light illumination.

OBJECTIVES: The objectives of this study were to verify use of a white light-illuminated adaptation of an established digital plaque image analysis (DPIA) technique to measure changes in plaque levels, and to compare the antiplaque efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice (SnF2/SHMP) and a 0.76% sodium monofluorophosphate/zinc citrate (ZnCit/SMFP) dentifrice using the white light DPIA system. METHODS: White Light DPIA Qualification--17 subjects were enrolled in the study. The following four images were captured on different days: a) non-disclosed morning plaque; b) disclosed morning plaque; c)just-brushed plaque; and d) post-prophylaxis plaque levels. Comparative Dentifrice Assessment-Following the qualification study, 21 subjects were enrolled in the dentifrice assessment. During Phase I (two weeks acclimatization phase), subjects used a standardized oral hygiene regimen twice per day, consisting of a sodium fluoride dentifrice and a standard flat-profile manual toothbrush. In Phase II (two-week treatment phase), subjects were randomized to one of two treatment groups: SnF2/SHMP dentifrice (Crest Pro-Health) or the ZnCit/SMFP formulation (Viadent). During each phase, plaque levels were assessed in the morning prior to the morning tooth brushing (a.m.), post-brushing in the morning (p.b.), and in the afternoon (p.m.). RESULTS: White Light DPIA Qualification--All 17 subjects completed the trial. The white light modification of DPIA successfully distinguished known variations in plaque coverage. Mean plaque coverage of the 12 anterior facial surfaces, as determined by the system for the four images, was: a) 0.07%; b) 11.44%; c) 4.99%; and d) 2.16%. Comparative Dentifrice Assessment-All 21 subjects completed the study. The SnF2/SHMP dentifrice provided a statistically significant 25% lower a.m. pre-brushing plaque level (p = 0.0385) versus ZnCit/SMFP. SnF2/SHMP also showed a directional 23% lower p.m. plaque (p = 0.09) level, and 15% less (p = 0.10) post-brushing plaque compared to ZnCit/SMFP. CONCLUSION: The white light DPIA system was shown to be a sensitive method to measure changes in plaque levels. Using this system, a SnF2/SHMP dentifrice was found to be significantly more effective than a ZnCit/SMFP dentifrice in the prevention of overnight plaque growth.

Placebo-controlled trial evaluating safety with 12-months continuous use of 6% hydrogen peroxide whitening strips.

OBJECTIVE: To assess the safety and tolerability of 6% hydrogen peroxide whitening strips over 12 months. METHODS: 80 adults were randomly assigned equally to one of two treatments: 6% hydrogen peroxide strips or placebo strips. Strips were worn 5 min daily for 12 months. Safety and tolerability were assessed via oral status interviews and oral examinations at baseline and after 1, 2, 3, 6, 9, and 12 months of use. RESULTS: Tooth sensitivity and oral irritation were the two most common adverse events. After 12 months use, tooth sensitivity was reported by 10% of subjects in the 6% strip group with a 95% confidence interval (CI) of (2.8%, 23.7%) and 5% of subjects in the placebo group with a 95% CI of (0.6%, 16.9%). The occurrence of reported oral irritation was 0% in the 6% strip group with a 95% CI of (0%, 8.8%) and 2.5% in the placebo strip group with a 95% CI of (0.1%, 13.2%). The occurrence of observed oral irritation was also similar between groups. The groups did not differ significantly (p>0.67) for the percent of subjects with each type of adverse event. In the 6% strip group, two subjects discontinued product use due to an adverse event (tooth sensitivity) compared to no subjects in the placebo group. Groups did not differ significantly (p>0.49) with respect to this outcome. CONCLUSION: Use of 6% hydrogen peroxide whitening strips over 12 months resulted in a safety profile similar to that seen with placebo strips.

Effects of a tartar control whitening dentifrice on tooth shade in a population with long-standing natural stain.

Changing and whitening tooth color in people with long-standing tooth stain without excessive hard tissue abrasion may represent one of the more difficult challenges for whitening dentifrices. An eight-week clinical trial was conducted to evaluate change in tooth color by a silica-based, enamel-safe tartar control whitening dentifrice compared to a marketed baking soda dentifrice control. First, a screening exercise was conducted to identify individuals with long-standing extrinsic dental stain. This exercise targeted adults who reported "stained teeth" and coffee/tea drinking or smoking, but who had no recent history of dental prophylaxis. Targeted subjects were examined for stain (Lobene Index) and tooth shade/color (Vita). A total of 291 adults having extrinsic stain and discolored teeth were enrolled in the study. Subjects were randomized to one of the two treatment groups, and all dentifrice use was unsupervised. Tooth color was measured at 4 and 8 weeks from shade values collected from the 8 incisors, and averages were determined from a linear ordering of the shade guide. A total of 278 evaluable subjects completed the 8-week study. Overall, the tartar control whitening dentifrice group experienced an improvement in color, differing statistically from baseline (p < 0.001) and from the marketed control (p < 0.05). Safety profiles for the two dentifrices were generally similar. Among patients with long-standing extrinsic stain, use of the tartar control whitening dentifrice resulted in superior overall tooth shade and reduced maximum or worst color compared to the marketed baking soda dentifrice control.

Comparative efficacy and tolerability of two direct-to-consumer tooth whitening systems.

PURPOSE: To compare the clinical response of two self-directed vital bleaching systems under market use conditions. MATERIALS AND METHODS: A randomized, parallel-group clinical trial was conducted. A total of 20 healthy adults were randomized to either a 6.0% hydrogen peroxide strip-based bleaching system or a combination system involving a 10% carbamide peroxide gel in a stock tray along with an anticavity whitening dentifrice and after-bleaching whitening mouthrinse. Only the maxillary arch was bleached over a 14-day period. Subjects were evaluated at 3, 8 and 15 days. Efficacy was measured objectively using digital image analysis to derive individual color parameters (L*a*b*) and overall color change (deltaE*). RESULTS: After 14 days, the adjusted mean reduction in yellow (Ab*) was -2.23 +/- 0.157 for the whitening strips compared to -0.97 +/- 0.188 for the combination system. This represented a highly statistically significant (P< 0.0001), two-fold superior reduction in yellowness for the whitening strip group compared to the marketed control. Similar results were seen for other color parameters, with the whitening strip group exhibiting two-fold color improvement relative to the tray/dentifrice/rinse combination. With respect to tolerability, tooth sensitivity and oral irritation were the most common findings. Considering event duration and severity, median bleaching tolerability severity-days scores were 0.07 and 0.58 for the strip and combination systems respectively, with these treatments differing statistically (P= 0.04 1) favoring the whitening strips.

Adenosine myocardial protection: preliminary results of a phase II clinical trial.

OBJECTIVE: To evaluate the safety, tolerance, and efficacy of adenosine in patients undergoing coronary artery bypass surgery. SUMMARY BACKGROUND DATA: Inadequate myocardial protection in patients undergoing coronary artery bypass surgery contributes to overall hospital morbidity and mortality. For this reason, new pharmacologic agents are under investigation to protect the regionally and globally ischemic heart. METHODS: In a double-blind, placebo-controlled trial, 253 patients were randomized to one of three cohorts. The treatment arms consisted of the intraoperative administration of cold blood cardioplegia, blood cardioplegia containing 500 microM adenosine, and blood cardioplegia containing 2 mM adenosine. Patients receiving adenosine cardioplegia were also given an infusion of adenosine (200 microg/kg/min) 10 minutes before and 15 minutes after removal of the aortic crossclamp. Invasive and noninvasive measurements of ventricular performance were obtained before, during, and after surgery. RESULTS: The high-dose adenosine cohort was associated with a trend toward a decrease in high-dose dopamine support and a lower incidence of myocardial infarction. A composite outcome analysis demonstrated that patients who received high-dose adenosine were less likely to experience one of five adverse events: high-dose dopamine use, epinephrine use, insertion of intraaortic balloon pump, myocardial infarction, or death. The operative mortality rate for all patients studied was 3.6% (9/253). CONCLUSIONS: Adenosine treatment is safe and well tolerated and may be associated with fewer postoperative complications.

Panel discussion. Data needs in cancer.

A prospective, comprehensive outcomes database was recently initiated by the National Comprehensive Cancer Network (NCCN) after a 2-year study to test data collection methods and systems. It started with data on 400 patients with newly diagnosed breast cancer at five NCCN sites, and over the next 3 years is projected to grow to include more than 12,000 patients with common cancers treated at all eligible NCCN sites. Among the goals of the database are: 1) to establish the capability to select, analyze, and report patterns of care and outcomes; 2) to allow NCCN members to assess their compliance with NCCN clinical practice guidelines and benchmark their performance against the rest of the NCCN; 3) to establish a true databased continuous quality improvement program; 4) to support clinical disease-oriented research and methodologic studies; and 5) to provide the NCCN with a vehicle for forging partnerships with others in the health-care field, such as the pharmaceutical industry, regulatory agencies, and accrediting bodies. Many of those potential partners were represented on this panel. Panelists discussed the data needs of their organizations, what they are doing to meet those needs, and how a comprehensive database will ultimately help improve patient care.