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.

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.

Relative anti-caries efficacy of 1100, 1700, 2200, and 2800 ppm fluoride ion in a sodium fluoride dentifrice over 1 year.

There is limited evidence from clinical trials on the dose response of sodium fluoride dentifrices at concentrations above 1100 ppm fluoride ion, with respect to caries efficacy. This randomized, double-blind study examined the anti-caries effectiveness of sodium fluoride dentifrices containing 1700 ppm, 2200 ppm and 2800 ppm fluoride ion relative to an 1100 ppm fluoride ion control. A population of 5439 elementary schoolchildren, aged 6-15 years, was recruited from an urban central Ohio area with a low fluoride content water supply (<0.3 ppm). Subjects were examined by visual-tactile and radiographic examination at baseline and after 1, 2, and 3 years of using the sodium fluoride dentifrices. Subjects were stratified according to gender, age and baseline DMFS scores derived from the visual-tactile baseline examination and randomly assigned to one of four treatment groups: 0.243% sodium fluoride (1100 ppm fluoride ion), 0.376% sodium fluoride (1700 ppm fluoride ion), 0.486% sodium fluoride (2200 ppm fluoride ion), and 0.619% sodium fluoride (2800 ppm fluoride ion). All products were formulated with the same fluoride compatible silica abrasive. Results after 1 year provided evidence of a positive sodium fluoride dose response. Compared to the 1100 ppm fluoride treatment group, the 1700 ppm fluoride treatment group had an 11.0% reduction in DMFS that was not statistically significant, while the 2200 ppm and 2800 ppm fluoride treatment groups showed statistically significant (P<0.05) reductions of 18.6% and 20.4%, respectively. The reductions in caries delivered by the higher fluoride dentifrices were present across all tooth surface types, but were most pronounced for occlusal surfaces. Results at years 2 and 3 were confounded by a concurrent fluoride rinse program, which involved portions of the study population. While the trends for the higher fluoride dentifrices observed at year 1 remained at years 2 and 3, the difference observed between treatments were substantially less and failed to reach statistical significance (P<0.05). Collectively, the data demonstrate that the 2200 ppm and the 2800 ppm fluoride treatments delivered statistically significantly greater caries efficacy than the 1100 ppm fluoride treatment. This large-scale clinical trial provides evidence of a positive statistically significant dose relationship between dental caries and sodium fluoride in a dentifrice at levels above 1100 ppm fluoride at year 1.

Reduction in dental caries with four concentrations of sodium fluoride in a dentifrice: a meta-analysis evaluation.

Information on the effects of fluoride concentrations above 1,100 ppm in dentifrices is not extensive in the literature. The objective of this meta-analysis was to examine and compare the anticaries effectiveness (in terms of DMFS scores) of 1,700 ppm, 2,200 ppm and 2,800 ppm F- ion (as sodium fluoride) dentifrices vs. an 1,100 ppm F- ion (as sodium fluoride) control dentifrice based on results from six double-blind, randomized clinical studies, each conducted over a two- to three-year period. The studies each enrolled approximately 1,200-2,000 male and female school children per treatment group in grades I through 8, and were conducted in areas with low fluoride content water supplies in the states of Indiana, Pennsylvania, Ohio and Oregon. Separate meta-analyses were performed on the study results (DMFS increment scores determined by visual-tactile examinations supplemented with radiographs) for the one-year, two-year and three-year examinations. Comparisons of the 1,700 ppm F-, 2,200 ppm F-, and 2,800 ppm F- groups vs. the 1,100 ppm F- group were based on pooling the effect sizes for these comparisons from the individual studies. The effect sizes were calculated in two different ways, reflecting the analyses that were performed in the original studies: 1) effects based on the sample means and variances; and 2) effects based on the adjusted sample means and mean squared error from an analysis of covariance. The results obtained from this meta-analysis provide evidence that the use of a 2,800 ppm F- ion, as sodium fluoride, dentifrice results in statistically significantly lower caries increment than the use of an 1,100 ppm F- ion, as sodium fluoride, dentifrice. This result was noted after one, two, and three years of dentifrice use. The 1,700 ppm F- and 2,200 ppm F- dentifrice groups showed some directional advantages over the 1,100 ppm F- dentifrice group, however the analysis did not establish these groups as statistically significantly better than 1,100 ppm F-. The meta-analysis based on analysis of covariance results was somewhat more sensitive to treatment group differences than the analysis based on sample means and variances, as was expected.

Removal of extrinsic stain using a tartar control whitening dentifrice: a randomized clinical trial.

A nine-week, double blind clinical trial was conducted to evaluate the effectiveness of a novel tartar control whitening dentifrice with a silica-based abrasive system on induced dental stain. The study model involved three weeks of stain induction followed by six weeks of unsupervised brushing to assess efficacy. To induce stain, 222 healthy adult volunteers received a dental prophylaxis, and then began a limited brushing regimen supplemented by three-times daily rinsing with tea and once daily rinsing with 15 ml of 0.12% chlorhexidine. This regimen was suspended, and 187 subjects with tooth stain were entered into a six-week clinical trial where they were randomized to either a silica-based tartar control whitening dentifrice or a marketed regular dentifrice control, balancing for stain levels and smoking status. At baseline, three and six weeks, stain area and stain intensity were measured on the 8 anterior teeth using the Lobene Index. After six weeks' use, composite Lobene means were 35% lower for the whitening dentifrice compared to the regular control. In addition to the overall reductions, there were statistically significant reductions in stain area (p < 0.015) and stain intensity (p < 0.01) at both three and six weeks. The tartar control whitening dentifrice was effective in removing stain on the gingival margins and elsewhere on the body of the tooth. Safety profiles for the two test dentifrices were generally similar. After three and six weeks' use, the tartar control whitening dentifrice reduced chlorhexidine and tea stain compared to the marketed control.

Maintenance of tooth color after prophylaxis: comparison of three dentifrices.

Pellicle rapidly accumulates on tooth surfaces after prophylaxis and may acquire cosmetically unacceptable levels of stain. A three-month clinical trial was conducted to evaluate stain prevention by a new silica-based tartar control whitening dentifrice (Crest Extra Whitening) compared to marketed tartar control baking soda peroxide whitening and regular dentifrice controls. Prior to the trial, a one-month screening exercise was conducted to identify adult subjects who accumulated extrinsic tooth stain after dental prophylaxis. A total of 672 subjects were stratified based on tooth whiteness, gender and tobacco usage, then given a dental prophylaxis and randomized into one of three dentifrice treatment groups. All product use was unsupervised. Change in tooth whiteness (delta L*) was determined by comparing colorimeter measurements collected on the facial surfaces of the four central incisors at months 1 and 3 to baseline. Ninety-six percent of subjects completed the three-month study. At both one and three months, the two whitening dentifrices did not differ from baseline in terms of delta L*. In contrast, the regular control had delta L* values of -0.26 and -0.39 at one and three months, respectively, differing significantly from baseline at both time points. Each of the whitening dentifrices differed statistically from the regular control in stain accumulation (p < or = 0.001) at one and three months, but were not different from each other. In general, all three test dentifrices were well tolerated. These data demonstrate the effectiveness of the new tartar control whitening dentifrice in preventing stain accumulation after dental prophylaxis compared to the marketed regular dentifrice control.

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.

Vital bleaching with whitening strips: summary of clinical research on effectiveness and tolerability.

Rapid innovation in vital bleaching has increased the popularity of tooth whitening among dental professionals and patients. A broad range of peroxide-based treatments are currently available including those that are professionally-administered (in-office), professionally-dispensed (custom-tray-based systems), and self-directed (over-the-counter). Recently, a novel, flexible polyethylene bleaching strip was introduced that delivers a hydrogen peroxide bleaching gel to the anterior dentition. This "trayless" system, available in professional-strength and over-the-counter versions, reportedly offers advantages with respect to overall peroxide dose, contact time, and ease-of-use compared to other delivery systems. This paper reviews the relevant published clinical research on whitening strips tested among a broad range of patients commonly encountered in contemporary dental practices.

Vital tooth whitening with a novel hydrogen peroxide strip system: design, kinetics, and clinical response.

For many years, at-home whitening has been used with great success and produces some of the most satisfying results of all dental procedures. Historically, the most common procedure used was a custom-fabricated tray loaded with a 10% carbamide peroxide gel that was worn overnight. Today, many manufacturers offer higher concentrations (15% and 20% carbamide peroxide) for faster results. Regardless of the peroxide concentration used, the custom tray delivery system has remained essentially the same. Recently, a trayless whitening system was developed that does not require any prefabrication or gel loading. The new delivery system is a thin, conformable strip precoated with an adhesive hydrogen peroxide gel. Each preloaded strip is presented on a backing liner. To use the strip, it is peeled off of the backing liner and applied to the facial surfaces of the anterior teeth. Each strip is worn for 30 minutes, removed, and discarded. The strip holds the gel in place for sufficient time to allow the peroxide to intrinsically and extrinsically whiten the teeth. The highly flexible strips conform intimately to the tooth surface and provide a uniform, controlled application of the peroxide gel.

A randomized clinical trial comparing a novel 5.3% hydrogen peroxide whitening strip to 10%, 15%, and 20% carbamide peroxide tray-based bleaching systems.

A randomized and controlled, parallel-group clinical trial compared the whitening benefits of a novel 5.3% hydrogen peroxide bleaching strip to 10%, 15%, and 20% carbamide peroxide tray-based bleaching systems. A total of 36 healthy adults were randomized to a 14-day regimen in which both arches were whitened for 1 hour per day in the whitening-strip group or 2 hours per day in the tray groups. Efficacy was measured objectively using digital images of the anterior teeth at baseline and after 14 days of treatment. Overall tooth color (L*a*b*) was derived from individual pixel values, and then mean levels of delta b*, delta L*, and composite color (delta E*) were compared using analysis of covariance. After 14 days of treatment, all groups experienced a greater than 1-unit mean improvement in delta b*, delta L*, and delta E* relative to baseline. For the primary study variable, reduction of yellow (delta b*) outcomes after 14 hours of using the experimental strip were comparable to those observed with the 10% tray group after 28 hours of use. These two treatment groups did not differ statistically with respect to any of the color measurements used in this study. For the tray groups, there was a reasonable dose relationship for the primary end point, delta b*, with the 15% and 20% tray groups averaging 17% and 68% improvements in yellow, respectively, over the 10% group. Except for the 20% carbamide peroxide system, where sensitivity was relatively common, all test products were well tolerated. In this first comparative evaluation vs marketed controls, use of the whitening strips twice daily for 14 days yielded a highly significant improvement in tooth color vs baseline.

Impact of demographic, behavioral, and dental care utilization parameters on tooth color and personal satisfaction.

A cross-sectional survey across broad age ranges was conducted to evaluate demographic, behavioral, and treatment parameters that impact tooth color and its perception. The sample included 180 US adults and teenagers, with a comparable representation of males and females in 6 different age strata, ranging from 13 to 64 years. Tooth color (L*a*b*) was measured on the maxillary central incisors using a spectrophotometer, and first-person satisfaction with tooth color was assessed using a five-point qualitative scale. Demographic, behavioral, and oral care parameters were modeled using multiple regression analysis. After adjusting for other explanatory variables, age, gender, coffee/tea consumption, and dental care all significantly affected yellowing (b*) and brightness (L*). Dental-visit frequency was the only factor that significantly predicted self-satisfaction with tooth color, explaining just 3% of the overall variability. First-person dissatisfaction with tooth color was common and found in most demographic and behavioral cohorts. Although age contributed to objectively measured tooth discoloration, personal satisfaction with tooth color was age-independent. These results suggest that the need or demand for esthetic dentistry may be broad-based and transcend stereotypical perceptions.

Shifting paradigms in whitening: introduction of a novel system for vital tooth bleaching.

The advent of whitening strips (Crest Whitestrips) affords a novel system for peroxide delivery without custom tray fabrication. In addition to generalized bleaching indications, clinical applications may leverage the low overall dose and short wearing regimen with the easy-to-use strips. The impact of these strips on the dental practice may be direct, as a result of increased accessibility via professional or personal use, or indirect, because of advertising and research in the area of tooth whitening.

Anticalculus effects of a novel, dual-phase polypyrophosphate dentifrice: chemical basis, mechanism, and clinical response.

A primary patient motivation for oral hygiene is effective cleaning. Dentifrice serves this function by including ingredients such as abrasives, surfactants, and specialized cleaning ingredients such as anticalculus agents. This introductory article aims to introduce professionals, educators, and researchers on the rationale behind the development of an improved cleaning dentifrice formulation, Crest Multicare Advanced Cleaning. This new dentifrice is based upon the application of an improved tartar control/cleaning ingredient that is a polymeric adjunct of a pyrophosphate anion commonly applied in tartar control and stain control whitening dentifrices. The polypyrophosphate anion, also referred to as sodium hexametaphosphate, produces superior activity and substantivity on oral surfaces as compared to both pyrophosphate and some other commonly used dental cleaning ingredients and cleaning/conditioning adjuncts. The increased activity and substantivity translate into significant improvements in the prevention of dental stains and supragingival calculus and in the non-abrasive removal of dental stains. This article describes the structure of polypyrophosphate as compared to the parent pyrophosphate molecule, the rationale for its improved chemistry, and, in particular, its tartar control chemistry. In addition, the fundamental mechanisms of calculus formation and inhibition are reviewed. Lastly, a preliminary clinical study evaluating the improved efficacy of a polypyrophosphate dentifrice is described where the tartar control activity of the polypyrophosphate dentifrice is shown to be superior to that of a clinically established and marketed industry standard pyrophosphate dentifrice.

Safety and efficacy of a novel tartar control dentifrice containing 3.3% pyrophosphate: a controlled six-month clinical trial.

This study was undertaken to establish the tartar control efficacy and long-term safety of a new tartar control dentifrice that was formulated to enhance aesthetics and consumer acceptability. In a partially randomized, examiner-blind clinical trial, the experimental dentifrice, Crest MultiCare with 3.3% pyrophosphate, was compared to two currently marketed control dentifrices, Crest Regular Paste or Crest Tartar Protection Paste with 5.0% pyrophosphate. The eight-month trial model included a two-month pretest period to establish calculus formation after prophylaxis, followed by a six-month test period to evaluate efficacy and safety. Following the pretest period, 456 subjects were allocated to one of the three treatment groups and then monitored for calculus accumulation. After three and six months' test product use, the Crest MultiCare group experienced reductions in calculus accumulation of 28.9% and 32.3%, respectively compared to the regular control dentifrice. Over the six-month observation period, the experimental tartar control and the marketed tartar control dentifrices were comparable on adverse event frequency, type or severity, and no subject discontinued treatment due to an oral soft tissue adverse event. In this partially randomized and controlled six-month clinical trial, this new dentifrice exhibited tartar control efficacy, with a comparable overall safety profile to a marketed tartar control dentifrice.

Retention, antimicrobial activity, and clinical outcomes following use of a bioerodible tetracycline gel in moderate-to-deep periodontal pockets.

This randomized, examiner masked, split mouth study evaluated a new model to test periodontal therapy involving a novel bioerodible copolymer gel containing tetracycline hydrochloride. Responses to the tetracycline gel and untreated control were compared for product tolerance and 3 different measures of effectiveness (drug retention, changes in microbial levels, and clinical status). The test gel was administered by syringe into the periodontal pockets of 18 systemically healthy adult volunteers, each of whom presented with 3 or more sites with 6 mm probing depths. Gingival crevicular fluid samples were used to monitor daily drug levels over 7 days, while clinical responses were assessed at day 30. Overall, the test gel was well-tolerated by all patients. For the 3 effectiveness measures, tetracycline was released throughout the observation period and mean levels exceeded 100 microg/mL over 6 days, statistically significant reductions in selected periodontal pathogens were evident at day 7 but not at day 30, and mean probing depth reductions at test sites were 1.12 mm at 30 days versus 0.36 mm at untreated control sites (P=0.012). The safety profile, longer-term drug retention, antimicrobial activity, and clinical response in this Phase I study suggest that this tetracycline-containing copolymer gel platform may represent a safe and effective bioerodible therapy for periodontitis. The experimental model also shows merit for early phase clinical testing of novel therapeutic agents.

Perioperative use of 0.12% chlorhexidine gluconate for the prevention of alveolar osteitis: efficacy and risk factor analysis.

OBJECTIVES: The purposes of this study were to evaluate the use of 0.12% chlorhexidine gluconate as a prophylactic therapy for the prevention of alveolar osteitis and to further examine subject-based risk factors associated with alveolar osteitis. STUDY DESIGN: The trial was a randomized, double-blind, placebo-controlled, parallel-group study conducted among 279 subjects, each of whom required oral surgery for the removal of a minimum of one impacted mandibular third molar. Subjects were instructed to rinse twice daily with 15 ml of chlorhexidine or placebo mouthrinse for 30 seconds for 1 week before and 1 week after the surgical extractions. This regimen included a supervised presurgical rinse. Alveolar osteitis diagnosis was based on the subjective finding of increasing postoperative pain at the surgical site that was not relieved with mild analgesics, supported by clinical evidence of one or more of the following: loss of blood clot, necrosis of blood clot, and exposed alveolar bone. RESULTS: In comparison with use of the placebo mouthrinse, prophylactic use of the chlorhexidine mouthrinse resulted in statistically significant (p < 0.05) reductions in the incidence of alveolar osteitis. With chlorhexidine therapy, the subject- and extraction-based incidences of alveolar osteitis in the evaluable subset (271 subjects) were reduced, relative to placebo, by 38% and 44%, respectively. The corresponding odds ratios that describe the increased odds of experiencing alveolar osteitis in the placebo group were 1.87 and 2.05 for subject- and extraction-based analyses, respectively. In comparison with nonuse of oral contraceptives, the use of oral contraceptives in female subjects was related to a statistically significant increase in the incidence of alveolar osteitis (odds ratio = 1.92, p = 0.035). Relative to male subjects, the observed incidence of alveolar osteitis for female subjects not using oral contraceptives was not statistically significant (odds ratio = 1.18, p = 0.64). Smoking did not increase the incidence of alveolar osteitis relative to not smoking (odds ratio = 1.20, p = 0.33). CONCLUSIONS: These data confirm that the prophylactic use of 0.12% chlorhexidine gluconate mouthrinse results in a significant reduction in the incidence of alveolar osteitis after the extraction of impacted mandibular third molars. In addition, oral contraceptive use in females was confirmed to be a risk factor for the development of alveolar osteitis.

Breath effects of three marketed dentifrices: a comparative study evaluating single and cumulative use.

This randomized and controlled, examiner blind, parallel group study was undertaken to evaluate the efficacy of three commercial dentifrices on breath malodor. A total of 384 healthy adult subjects with oral malodor were randomized to one of four brushing groups, using either an antimicrobial dentifrice containing 0.45% stannous fluoride, an antitartar dentifrice containing 0.243% sodium fluoride and 5% pyrophosphate, an antimicrobial dentifrice containing 0.24% sodium fluoride and 0.30% triclosan/copolymer, or bottled distilled water which served as the negative experimental control. Breath quality was evaluated over a five-day period by second-person organoleptic grading and measurement of volatile sulfur levels. Following treatment, adjusted mean organoleptic scores and volatile sulfur levels were lowest for the stannous fluoride dentifrice group, with this group exhibiting superior breath quality compared to the negative control at three hours after a single brushing, and again at all cumulative use time points. While all test dentifrices showed some activity, only stannous fluoride had a second-person breath benefit. Breath effects for the other two dentifrices were limited to reductions in volatile sulfur levels at hours 99 and 104 for the antitartar sodium fluoride pyrophosphate dentifrice, and at hour 99 only for the antimicrobial sodium fluoride triclosan/copolymer dentifrice. This research establishes the comparative breath efficacy of three commercial dentifrices in a study model that may prove relevant for other dentifrice clinical trials.

Gingival fluid tetracycline release from bioerodible gels.

Intracrevicular antimicrobial therapy is consistent with the site-specific nature of periodontitis. Considerable research has focused on the use of nonresorbable fibers. However, a bioerodible system is desirable. The purpose of this study was to assess tetracycline release and safety following a single application of a syringable 35% tetracycline hydrochloride in a lactic-glycolic acid gel. 31 generally healthy adult volunteers (mean age = 59 years) were enrolled in and completed this randomized, double-blind eight day study. 2, 6-10 mm non-adjacent interproximal pockets that bled on pocket probing were chosen as experimental sites in each subject. I experimental site and the surrounding gingival crevice received small particle size tetracycline in gel while the other site received larger particle size tetracycline in gel. Gingival crevicular fluid (GCF) was collected prior to treatment and 15 min, 1, 2, 3, 4 and 8 days post-treatment. GCF tetracyline concentrations were determined by agar diffusion bioassay and GCF volume measurements. 61% and 71% of sites had > or = 100 micrograms/ml tetracycline 3 days following application of large (mean concentration = 430 +/- 92 micrograms/ml) and small particle gels (mean concentration = 418 +/- 70 micrograms/ml), respectively. 37% and 55% of sites had measurable tetracycline 8 days after placement of large (mean concentration = 86 +/- 31 micrograms/ml) and small particle gels (mean concentration = 293 +/- 79 micrograms/ml), respectively. The most common adverse event was "bitter taste" (10% of subjects). Based upon the reduction in probing depths and % of sites bleeding on probing at 8 days relative to pretreatment, and the absence of any serious adverse events, it is concluded that these bioerodible gels are safe, and since the bacteriostatic range for most putative periodontopathogens is in the 2-10 micrograms/ml range, the tetracycline levels observed at days 3 and 8 likely represent significant antimicrobial efficacy.

Efficacy of quantitative digital subtraction radiography using radiographs exposed in a multicenter trial.

Digital subtraction radiography (DSR) has been shown to be a sensitive and specific method for the detection of small bony changes in periodontitis. The purpose of this study was to perform a multicenter validation of the DSR in human subjects. Seventeen subjects were enrolled at 3 centers. Feather-edged hydroxyapatite chips (approximately 1, 7 and 10 mg) were used to simulate osseous lesions. Bilateral radiographs were taken with and without chips. Geometry was standardized using a cephalostat and the order of radiographs was determined using a randomization plan. Radiographs were subtracted, lesions isolated, and quantified at a single center without knowledge of the randomization code or location of the chips used in each subject. The overall sensitivity and specificity in detecting 1 mg changes was 87.8% and 100%, respectively. Sensitivity and specificity in detecting 7 mg and 10 mg chips was 100%. A strong linear relationship between actual lesion mass and calculated mass was observed (R2 = 0.94, slope = 0.98, p < 0.0001). No significant differences were observed by center. These data indicate that the DSR is a valid technique for the assessment of alveolar bone changes in multicenter trials.