The Effect of Use of a Sonic Power Toothbrush and a Manual Toothbrush Control on Plaque and Gingivitis.

OBJECTIVES: To compare the ability of the Philips Sonicare DiamondClean power toothbrush and the ADA Reference manual toothbrush to reduce plaque and gingival inflammation by routine manual toothbrush users. METHODS: This was a randomized, single-blind, parallel-design study. Eligible subjects were generally healthy non-smokers who exhibited mild to moderate gingivitis upon study entry. Enrolled subjects were randomly allocated to commence twice-daily home use of either a Philips Sonicare DiamondClean (DiamondClean) power toothbrush or an ADA reference manual toothbrush (MTB) for a period of four weeks. Clinical safety and efficacy were assessed after a two- and four-week period of home use. Statistical analysis was performed for the modified intent to treat (mITT) population using a mixed model with the Baseline score as a covariate. RESULTS: A total of 182 volunteers were screened, 144 (72 per treatment) were randomized, and 142 subjects completed this study. Following four weeks of use, the Least Square (LS) Mean SE) percent reduction in surface plaque was 34.9% (1.8) for DiamondClean and 8.0% (1.7) for MTB, (p < 0.0001). At the same four-week time point, the LS Mean (SE) percent reduction in gingival inflammation for DiamondClean was 25.5% (1.9) and 19.1% (1.9) for MTB (p = 0.0213). For gingival bleeding, the LS Mean (SE) percent reduction in sites with gingival bleeding for DiamondClean was 57.4% (3.06) and 31.4% (3.04) for MTB (p < 0.0001). CONCLUSIONS: The Philips Sonicare DiamondClean power toothbrush was statistically significantly more effective than a manual toothbrush in reducing supragingival plaque, gingival inflammation, and gingival bleeding following a four-week period of home use. Both products were safe for home use.

A 6-month clinical investigation of custom tray application of peroxide gel with or without doxycycline as adjuncts to scaling and root planing for treatment of periodontitis.

PURPOSE: To evaluate the 6-month clinical effects of one scaling and root planing (SRP) procedure alone or combined with local administration of hydrogen peroxide gel (with or without inclusion of doxycycline for 2 weeks) using periodontal medicament carriers in the form of customized prescription trays for treatment of subjects with chronic periodontitis. METHODS: Using a randomized controlled design, 61 subjects with moderate to advanced periodontitis were assigned to three parallel treatment groups: 1) SRP combined with prescription-tray (Perio Tray) application of 1.7% hydrogen peroxide gel (Perio Gel) and, for the first 2 weeks, doxycycline, 2) SRP combined with prescription-tray application of peroxide gel, and 3) SRP alone. All subjects brushed twice daily with standard dentifrice and toothbrush for a 4-week acclimation phase, and continued this regimen throughout the 6-month treatment phase. Pocket probing depth (PPD) and bleeding index (BI) were assessed on natural and restored sites at baseline and after 2, 5, 13, and 26 weeks. SRP was performed 3 weeks after baseline. Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval, analyzing natural and restored sites separately. RESULTS: 57 subjects completed the trial. Analysis of pockets > 5 mm at baseline showed that mean PPD for both test groups significantly decreased from baseline approximately 0.50 mm prior to SRP. Two weeks following SRP, mean PPD significantly decreased from baseline by > 0.90 mm for both test groups and 0.29 mm for the control. By 26 weeks, mean PPD decreased > 1.10 mm for both test groups compared to 0.38 mm for the SRP-only control (P < 0.001 for test versus control at all post-SRP comparisons). Analysis of pockets ≤ 5 mm at baseline showed the same relationship between groups (P < 0.001 for test versus control). Mean BI dropped significantly only for test groups before SRP, and the tray/peroxide-doxycycline group was significantly different from the control (P = 0.033). Two weeks post-SRP, mean BI reductions for test groups were significantly greater than the control, and remained so for most comparisons. For restored sites, mean PPDs of both test groups were significantly better (P < 0.05) than the control for all post-baseline comparisons.

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).

Custom tray application of peroxide gel as an adjunct to scaling and root planing in the treatment of periodontitis: results of a randomized controlled trial after six months.

OBJECTIVE: Scaling and root planing (SRP) is the primary non-surgical treatment for periodontitis, but its effectiveness is limited. Consequently, various adjunctive therapies have been investigated to improve clinical outcome. This study evaluated the clinical effects of one SRP procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months. METHODS: An examiner-blind clinical trial was conducted among 30 subjects with moderate to advanced periodontitis who were randomized to SRP alone or SRP combined with prescription custom-tray application (Perio Tray) of 1.7% hydrogen peroxide gel (Perio Gel) for a period of three months, then extended to six months. Following impressions for the test group, all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions (while trays were fabricated) prior to initiating the treatment phase. SRP was performed three weeks after baseline, and clinical assessments, i.e., pocket probing depth (PPD) and bleeding index (BI), were conducted at baseline and after two, five, 13, and 26 weeks of peroxide gel applications. Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval. RESULTS: A total of 13 test and 15 control subjects completed the original three-month trial, of whom 10 test and 13 control subjects finished the three-month extension. After two weeks of peroxide gel use prior to SRP, mean PPD for the test group significantly decreased from baseline by 0.21 mm and mean BI significantly dropped by 0.14; clinical parameters for the control group were unchanged. Two weeks following SRP, mean PPD significantly decreased from baseline by 0.65 mm for the test group and 0.17 mm for the control; mean BI significantly dropped by 0.17 for the test group and 0.05 for the control. Ten weeks following SRP, mean PPD decreases were 0.77 mm for the test group and 0.13 mm for the control, and mean BI reductions were 0.14 for the test group and 0.00 for the control. For subjects who completed the three-month extension (i.e., 23 weeks post-SRP), mean PPD decreases were 0.72 mm for the test group and 0.13 mm for the control, and mean BI reductions were 0.05 for the test group and 0.01 for the control. Analysis of deeper pockets (i.e., > 5 mm at baseline) showed the same relationship for PPD, but with larger differences between groups. For example, after two weeks of peroxide gel use prior to SRP, mean PPD decreased by 0.48 mm for the test group compared to 0.04 mm for the control. Two weeks after SRP, mean PPD decreased from baseline by 1.40 mm for the test group and 0.60 mm for the control, and 10 weeks after SRP by 1.57 mm for the test group and 0.58 mm for the control. After the extension (i.e., 23 weeks post-SRP), mean PPD changed from baseline by 1.50 mm for the test group and 0.55 mm for the control. With the exception of BI at 23 weeks post-SRP, all reductions cited above for the test group were statistically significantly different from the control group for both PPD and BI for all comparisons. CONCLUSION: When compared with SRP alone, clinical improvements in PPD (e.g., -1.0 mm for pockets > 5 mm at baseline) were maintained for up to six months after SRP with adjunctive use of 1.7% hydrogen peroxide gel, locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis.

Custom tray application of peroxide gel as an adjunct to scaling and root planing in the treatment of periodontitis: a randomized, controlled three-month clinical trial.

OBJECTIVE: Periodontitis is an inflammatory condition of the supporting dental tissues that is normally treated by mechanical removal of the subgingival biofilm. This mechanical treatment, generally known as scaling and root planing (SRP), is not entirely effective, and various adjunctive therapies have been investigated to improve the clinical outcome. This study evaluated the clinical effects of SRP alone or combined with local administration of hydrogen peroxide gel using customized trays in the treatment of subjects with chronic periodontitis. METHODS: An examiner-blind clinical trial was conducted among 30 subjects with moderate to advanced periodontitis, who were randomized to SRP alone or SRP combined with a prescription custom-tray application (Perio Tray) of 1.7% hydrogen peroxide gel (Perio Gel) for a period of three months. Following impressions for the test group, all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions (while trays were fabricated) prior to initiating the treatment phase. Clinical assessments, i.e., pocket probing depth (PPD) and bleeding index (BI), were conducted at baseline and after two, five, and 13 weeks of peroxide applications; SRP was performed three weeks after baseline. Clinical variables were compared by ANOVA and paired t-tests after each treatment interval. RESULTS: A total of 13 test and 15 control subjects completed the study. After two weeks of peroxide gel use prior to SRP, mean whole-mouth PPD was unchanged for the control group, but significantly decreased 0.21 mm in the test group. Two weeks following SRP, mean PPD decreased from baseline by 0.17 mm for the control group and 0.65 mm for the test group. Ten weeks following SRP, mean PPD decreases were 0.13 mm for the control group and 0.77 mm for the test group. After two weeks of peroxide use prior to SRP, mean whole-mouth BI decreased 0.03 (from 15% to 12%) for the control and 0.14 (from 23% to 9%) for the test group. Two weeks after SRP, the mean whole-mouth BI score decreased 0.05 from baseline (15% to 10%) for the control and 0.17 (23% to 6%) for the test group. Ten weeks after SRP, there was no change from baseline for the control group, but BI was 0.14 lower (23% to 9%) for the test group. Further analysis showed the same statistical relationship between groups for PPD assessments of deeper pockets. For pockets > or =6 mm at baseline, mean PPD decreased by 0.04 mm for the control compared to 0.48 mm for the test group after two weeks of peroxide gel use and prior to SRP. Two weeks after SRP, mean PPD decreased from baseline by 0.60 mm for the control and 1.40 mm for the test group, and 10 weeks after SRP by 0.58 mm for the control and 1.57 mm for the test group. All reductions cited above for the test group were statistically significantly different from the control group for both PPD and BI. CONCLUSION: The adjunctive use over three months of 1.7% hydrogen peroxide gel, locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis, demonstrated statistically significant clinical improvements in pocket depths and bleeding when compared with SRP alone.

Abrasion, polishing, and stain removal characteristics of various commercial dentifrices in vitro.

OBJECTIVE: To evaluate, using conventional in vitro procedures, the abrasivity, enamel polishing properties, and stain removal effectiveness of various commercial dentifrices that have a variety of compositions and are marketed for cleaning, whitening, and/or polishing capabilities, and to examine their relationships between stain removal and abrasivity. METHODS: The Relative Dentin Abrasivity (RDA) method was used to measure abrasivity, and the Pellicle Cleaning Ratio (PCR) procedure was used to evaluate stain removal performance. A Cleaning Efficiency Index (CEI) was calculated using the RDA and PCR values. Enamel polish was determined on bovine enamel specimens using a reflectometer. All treatments were performed on a V-8 cross-brushing machine using aqueous dentifrice slurries and standard nylon-bristle toothbrushes. A total of 26 dentifrices, purchased at retail, were tested against the American Dental Association (ADA) calcium pyrophosphate reference standard. RESULTS: All dentifrices removed extrinsic stain and produced some dentin abrasion, but scores ranged widely between products (from 36 to 269 for RDA and from 25 to 138 for PCR). The majority of dentifrices contained hydrated silicas, and those with high PCR scores often, but not always, had higher RDA values. Products containing other abrasives (e.g., dicalcium phosphate, sodium bicarbonate, and calcium carbonate) generally had lower RDA values and usually lower PCR scores. There were exceptions (e.g., refined kaolin clay) that had high PCR scores and low RDA values, resulting in higher CEI values. Similarly, brushing with all dentifrices significantly increased reflectance readings of acid-dulled teeth, but polish scores also were highly variable among products (ranging from 38 to 97). The polish scores of dentifrices containing hydrated silica varied extensively (ranging from 38 to 80), and the scores of products containing other abrasives fell within this same range, except for dentifrices containing either Fuller's earth (86) or kaolin (97). CONCLUSION: With only a few exceptions, dentifrices marketed as "whitening" products were generally more abrasive to dentin, especially for those containing silicas. Similarly, aside from two non-silica products, those dentifrices advertised for polishing ability generally were no more effective than other products. The relationship between stain-removal ability and abrasivity of dentifrices was not necessarily direct.

Clinical validation and calibration of in vitro peroxide tooth whitening.

OBJECTIVE: The purpose of this study was to validate and calibrate an in vitro test method for screening the performance of peroxide-containing toothpastes against actual clinical whitening performance. An additional objective was to estimate the whitening performance of a new peroxide-additive gel using the in vitro methodology. METHODS: A one-month longitudinal clinical study was performed to provide a benchmark for the in vivo intrinsic whitening performance of a peroxide-containing fluoride toothpaste. An in vitro study was then conducted, using freshly prepared slurries of the same peroxide-containing toothpaste in artificial saliva, to repeatedly treat extracted human teeth with natural intrinsic stain. The effect of cumulative treatment time on whiteness was determined using objective chromometer whiteness measurements (L*, a*, and b*), and more subjective Vita Shade guide (Vitapan) comparisons, and the results were correlated. A non-peroxide fluoride toothpaste was used as a negative control. The peroxide gel additive, combined in a 1:1 ratio with each of two non-peroxide toothpastes and diluted in artificial saliva, was evaluated using the same instrumental and subjective measures for in vitro whitening efficacy. The previously evaluated peroxide toothpaste and one of the non-peroxide toothpastes were used as positive and negative controls, respectively. RESULTS: In the clinical study, the peroxide-containing toothpaste produced a linear increase in tooth whiteness with time, achieving an approximately two Vita Shade guide improvement in whiteness at the end of four weeks. The same peroxide toothpaste in vitro produced a curvilinear increase in tooth whiteness versus cumulative treatment time, with a two-shade increase being achieved in 116 minutes. The non-peroxide control toothpaste produced less than half a shade guide increase in whiteness within the first 30 minutes, and none thereafter. Both the clinical and in vitro studies indicated that further whitening can be obtained with longer use of the peroxide-containing toothpaste or peroxide-additive gel. CONCLUSION: Treatment of naturally stained teeth in vitro with the peroxide toothpaste for 116 cumulative minutes produced the same two-shade increase in whiteness as obtained with twice-daily brushing for four weeks in vivo. The peroxide-additive gel, combined with a non-peroxide toothpaste, is projected to provide a similar two-shade increase in whiteness when used twice daily for four weeks. There are indications that greater intrinsic whiteness increase would be achieved with the peroxide toothpaste or with the peroxide-additive gel plus non-peroxide toothpaste with more extended regular twice-daily use in vivo.

A randomized crossover-design study to investigate the plaque removal efficacy of two power toothbrushes: Philips Sonicare Flexcare and Oral-B Triumph.

The Sonicare FlexCare and the Oral-B Triumph Professional Care 9000 power toothbrushes were compared in a single-use, examiner-masked, crossover clinical trial. Outcomes were evaluated using the Turesky Modified Quigley-Hein (TMQH) plaque index. Percent reduction in overall plaque score because of toothbrushing was the primary efficacy measure. Subjects were required to have a TMQH score > or = 1.8 at screening after refraining from oral hygiene for 24 hours. The study included three visits. At visit 1, subjects were randomized to one of two treatment sequences, given their first toothbrush and toothpaste, and instructed to use them twice daily for 2 minutes during a 1-week familiarization phase. Before visit 2, subjects again refrained from oral hygiene for 24 hours. At this visit, plaque scores were assessed before and after a 2-minute supervised brushing episode, then the second test product was issued. Familiarization, plaque accumulation, and clinical examinations were the same for both product use periods. Data were analyzed using a linear mixed effects model with subject as a grouping factor. Treatment effects were expressed as mean values and the appropriate 95% confidence intervals (CI). Ninety-six subjects were screened with 93 subjects completing the study. The sample's TMQH score at Visit 1 was 3.18 +/- 0.42 (mean +/- standard deviation [SD]). Full-mouth prebrushing plaque scores were 2.85 +/- 0.49 for FlexCare and 2.94 +/- 0.45 for Triumph. Respective full-mouth reductions in overall plaque score were 38.02% +/- 15.14% and 30.43% +/- 14.05%. The estimated treatment effect, expressed as difference between FlexCare and Triumph in percent plaque index reduction, was 7.59% with a 95% CI from 4.79% to 10.40%. Similar differences were observed for all subregions, including anterior, posterior, interproximal, and interproximal posterior sites. The same protocol design was used at an earlier study in another center. The combined overall treatment effect from the two studies was estimated at 6.97% (95% CI: 5.17%, 8.78%), favoring FlexCare.

A four-week clinical study to evaluate and compare the effectiveness of a baking soda dentifrice and an antimicrobial dentifrice in reducing plaque.

OBJECTIVE: To evaluate and compare the effectiveness in reducing plaque of a fluoride dentifrice containing baking soda and a non-baking soda fluoride dentifrice containing an antimicrobial (triclosan/copolymer) system after a single brushing and over a four-week period of daily brushing. METHODS: A total of 207 subjects completed this randomized, blinded, parallel-group clinical study. Twenty-four hour plaque buildup was scored at baseline and after two and four weeks of twice-daily use of the products. Additionally, controlled single brushing with the assigned dentifrice, followed by post-brushing plaque assessment, was performed at the start (baseline visit) and end (Week-4 visit) of the study. Plaque was scored using the Turesky, et al. modification of Quigley-Hein Index at six sites per tooth, according to Soparkar's modification. RESULTS: Mean baseline whole mouth plaque scores for the baking soda and triclosan dentifrice groups were 2.90 +/- 0.40 and 2.90 +/- 0.39, respectively, and the difference was not statistically significant. Within-group analysis showed that both products significantly reduced the amount of plaque over the four-week period (p < 0.001). Between-group analysis showed that brushing with the baking soda dentifrice exhibited significantly greater reduction in plaque scores (p < 0.001) after two and four weeks of brushing as compared to the triclosan dentifrice. After four weeks, the mean plaque reduction for the baking soda dentifrice group (0.34 +/- 0.32) was 2.22-fold greater than that observed for the triclosan dentifrice group (0.15 +/- 0.24). Similarly, single brushing with the baking soda dentifrice showed a 1.88- to 2.08-fold greater pre- to post-brushing plaque difference as compared to the triclosan dentifrice at the baseline visit (mean plaque reduction: baking soda 0.54 +/- 0.26; triclosan 0.28 +/- 0.18; ratio 1.88X) and Week-4 visit (baking soda 0.47 +/- 0.21; triclosan 0.23 +/- 0.15; ratio 2.08X). Similar to the whole mouth scores, evaluation of various tooth sites (facial, lingual, proximal, and gingival) showed a significantly greater reduction in plaque scores for brushing with the baking soda dentifrice as compared to brushing with the triclosan dentifrice. CONCLUSION: The results of this study indicate that the baking soda dentifrice was more effective than the non-baking soda, antimicrobial dentifrice in plaque removal after a single tooth brushing, and in maintaining significantly lower plaque levels during a four-week period of twice daily, unsupervised tooth brushing.

Enhancement of plaque removal efficacy by tooth brushing with baking soda dentifrices: results of five clinical studies.

OBJECTIVE: An earlier clinical study demonstrated that brushing with a commercial Arm & Hammer dentifrice containing baking soda physically removed significantly more plaque than brushing with either of two commercial dentifrices which did not contain baking soda. However, little has been done to confirm these results and to compare baking soda-containing dentifrices with more recently commercialized non-baking soda dentifrice formulations. The objective of this study was to compare commercial dentifrices containing 20% to 65% baking soda and commercial dentifrices without baking soda in enhancing plaque removal efficacy of tooth brushing. METHODS: Five randomized, controlled, blinded, crossover clinical studies were performed among healthy adult volunteers who provided informed consent. After approximately 24 hours without oral hygiene, subjects with sufficient plaque were enrolled in the study phase. Plaque was scored before and after supervised brushing for one minute using the Turesky, et al. modification of the Quigley-Hein Plaque Index at six sites per tooth according to Soparkar's modification as described by Lobene, et al. In each study, wash-out periods with a regular dentifrice not evaluated in the study separated each product treatment. RESULTS: In all studies, every dentifrice exhibited a significant (p < 0.0001) reduction in 24-hour plaque scores. Between-group comparisons of whole mouth plaque scores in all five studies demonstrated that brushing with baking soda dentifrices resulted in statistically greater (p < 0.01) reductions in whole mouth mean plaque scores than brushing with dentifrices that did not contain baking soda. Results on other tooth surfaces, such as facial, lingual, proximal, and gingival surfaces also demonstrated statistically greater (p < 0.05) reductions in mean plaque scores for the baking soda-containing dentifrices as compared to the baking soda-free dentifrices. In three of the studies comparing different levels of baking soda, brushing with dentifrices with higher concentrations of baking soda consistently removed numerically more plaque than those containing lower levels. In one of these three studies, the difference in plaque removal between the baking soda dentifrices reached statistical significance. The results suggest a positive relationship between plaque removal efficiency and baking soda concentration. CONCLUSION: The collective results from the five controlled clinical studies on over 270 subjects reported in this paper, consistently demonstrate that Arm & Hammer baking soda dentifrices enhanced plaque removal effectiveness of tooth brushing to a significantly greater extent than the non-baking soda dentifrice products.

Inhibition of calculus formation by dentifrice formulations containing essential oils and zinc.

PURPOSE: To examine the effect of three essential oil-containing dentifrice formulations with different zinc salts and concentrations on dental calculus formation in rats. MATERIALS AND METHODS: A total of 150 rats were randomly distributed into five litter and sex-matched groups of 30. They were maintained on a calculogenic diet and topically treated twice daily with undiluted dentifrices. Each experimental dentifrice formulation contained a zinc salt, a fixed combination of essential oils (i.e. eucalyptol, menthol, methyl salicylate, and thymol) and a hydrated silica abrasive. Commercial zinc-free and zinc-containing dentifrices were included as negative and positive controls, respectively. After 17 days calculus was scored post-mortem on molar teeth. RESULTS: All groups of rats treated with zinc-containing dentifrices had significantly (P < 0.05) lower mean calculus scores than the group treated with a zinc-free control dentifrice. Other variables (e.g. fomulation type, essential oil content, zinc salt and concentration) did not significantly affect calculus scores. Thus, all three essential oil/zinc-containing dentifrices and a commercial, zinc-containing, tartar-control dentifrice inhibited calculus formation in this rat model.

Comparison of a dual-phase fluoride toothpaste containing calcium, phosphate, and sodium bicarbonate with a regular fluoride toothpaste on calculus formation.

This clinical study compared the effect on dental calculus formation of a dual-phase fluoride dentifrice containing sodium bicarbonate, calcium, and phosphate with that of a regular dentifrice using a short-term clinical model in which calculus formation was facilitated. A total of 87 adult volunteers completed this study, which was a double-blind, parallel-group design, consisting of 2-week pretrial and trial periods separated by a washout period. A partial-mouth technique was used wherein the lower anterior teeth were protected from brushing by a custom-fitted toothshield, which doubled as an applicator for an undiluted dentifrice, twice daily. Calculus was measured on the labial/lingual surfaces of six lower anterior teeth by the Volpe-Manhold Index (V-MI). Subjects used a non-tartar-control dentifrice during the pretrial period to determine calculus formation rates, and these V-MI scores were used as baseline data for random allocation to either a control or test product for the trial period. Subjects who were accepted into the study, based on existing tartar deposits, readily formed calculus during the pretrial period using the toothshield method. During the trial period, subjects who were assigned the test dentifrice had comparable amounts of calculus accumulation to those who used the control dentifrice. However, subjects in the test dentifrice group had significantly lower (16%) calculus scores on lingual surfaces than those in the control group. Intragroup comparisons of V-MI data from the pretrial period with those from the trial period provided similar overall results to the comparisons between groups. This study demonstrated that a dual-phase baking soda dentifrice containing calcium and phosphate did not increase calculus accumulation relative to a regular dentifrice when used by adults with a propensity for developing calculus.

Extrinsic tooth stain removal efficacy of a sodium bicarbonate dual-phase dentifrice containing calcium and phosphate in a six-week clinical trial.

OBJECTIVE: The objective of this clinical investigation was to evaluate the effectiveness in removing existing extrinsic tooth stains of a sodium bicarbonate (baking soda), dual-phase dentifrice containing calcium and phosphate (Test Dentifrice), when compared to a commercial hydrated silica dentifrice (Control Dentifrice), during a six-week period of normal, unsupervised use. METHODOLOGY: This investigation was a double-blind comparison of two equivalent, parallel groups of subjects assigned to use different dentifrices for six weeks. A total of 108 adult male and female subjects qualified for the trial based on the presence of existing extrinsic tooth stains and other inclusion/exclusion criteria. The two groups were balanced for gender, tobacco use, and extrinsic tooth stain scores, and randomly assigned the Test or Control dentifrices. All subjects were instructed to brush their teeth twice daily using only the dentifrice and toothbrush provided, and to refrain from using any other oral hygiene products for the duration of the study. Although product usage was unsupervised after the baseline visit, subjects maintained a treatment diary, and product consumption was monitored to estimate compliance. Oral soft and hard tissue and extrinsic stain assessments (Modified Lobene Stain Index) for each subject were conducted at baseline and after two, four, and six weeks of product use. RESULTS: A total of 107 subjects complied with the protocol and completed the six-week study. Compared to baseline, at the two-, four-, and six-week examinations the Test Dentifrice group had statistically significant reductions in extrinsic tooth stain. In contrast, the Control Dentifrice group did not attain significant reductions from baseline at any of the exams. At both the four-week and six-week examinations, the Test Dentifrice group had significantly lower levels of extrinsic tooth stain than the Control Dentifrice group. CONCLUSION: A sodium bicarbonate, dual-phase dentifrice containing calcium and phosphate demonstrated statisically significant efficacy in removing naturally acquired, extrinsic tooth stain, and was significantly more effective for stain removal than a commercially available, hydrated silica dentifrice.

An investigation into the effect of three months' clinical wear on toothbrush efficacy: results from two independent studies.

OBJECTIVE: Limited evidence has suggested that a worn toothbrush may be significantly less effective than a new brush with respect to plaque removal. Two independent studies, one with a manual toothbrush and one with a powered toothbrush, were undertaken to compared the ability of these toothbrushes as new and after three months' use to remove plaque. METHODOLOGY: Subjects from a general population were given either an Oral-B CrossAction manual toothbrush (Study 1) or a Braun Oral-B Battery (D4) toothbrush (Study 2). They were instructed to use their respective toothbrushes twice per day for a period of three months. After this time, those subjects meeting the studies' respective inclusion criteria entered the single-use, cross-over phase of the two studies. Both studies involved disclosing the teeth prior to measuring plaque. In Study 1, plaque was recorded using the Proximal Marginal Plaque Index and subjects brushed for one minute, by random assignment, with either a new or a worn toothbrush. In Study 2, plaque was measured using the Modified Quigley-Hein Plaque Index and subjects brushed for two minutes with either new or used brush heads, by random assignment. After a period of approximately one week, subjects returned to the test facilities and brushed with the alternate brush. RESULTS: Study 1 showed that both the new and the worn CrossAction toothbrushes significantly reduced plaque scores (p < 0.0001). A comparison of the two toothbrushes revealed no significant difference for whole-mouth plaque scores; however, at approximal sites the new toothbrush was significantly more effective than the worn brush (p = 0.033). In Study 2, as in Study 1, brushing with either a new or a worn brush head significantly reduced plaque scores (p < 0.0001). A comparison of the efficacies of the new and worn D4 toothbrushes revealed a non-significant tendency for the new brush head to remove more plaque than the worn brush head. However, when plaque removal was assessed for subjects using brush heads with the most extreme wear, i.e., scores of 3 or 4 (n = 15), a significant difference (p < 0.05) between new and worn brush heads was observed for the whole-mouth and approximal surfaces. CONCLUSION: The results from these two studies provide further data in support of the hypothesis that a worn toothbrush is less efficient with respect to plaque removal than a new brush. Patients should therefore be encouraged to replace their toothbrush regularly before bristle wear becomes excessive.