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

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

Impact of a novel power toothbrush with SmartGuide technology on brushing pressure and thoroughness.

AIM: Toothbrushing effectiveness can be improved with at-home reinforcement of proper technique. This study evaluated the ability of a power brush with a wireless remote display (Oral-B Triumph with SmartGuide) to improve brushing force and thoroughness. METHODS AND MATERIALS: At baseline, 61 pre-screened subjects were videotaped while brushing. The wireless display was also videotaped. Subjects were then randomized to the power brush alone or the power brush with the wireless display. After 30 days of home use, subjects returned and brushed for two minutes using a two-way mirror. Brushing behavior and the wireless display were videotaped. RESULTS: Fifty-eight subjects were included in the pressure sensor analysis. The reduction in pressure sensor activation time at day 30 versus baseline was 88.5% for the power brush with wireless display and 53.4% for the power brush alone. The difference between groups was statistically significant in favor of the power brush with display (p=0.034). Forty-six subjects were included in the brushing thoroughness assessment. Subjects using the power brush with the wireless display showed statistically significantly more thorough brushing across the dentition and lingual/buccal surfaces relative to baseline. The power brush alone did not show a significant difference relative to baseline. CONCLUSION: Subjects using the power brush with the wireless display brushed with less force than subjects using the power brush alone after 30 days of home use. CLINICAL SIGNIFICANCE: The power brush with the wireless display can be incorporated in patients' home care routine to improve brushing technique, including brushing pressure and thoroughness.

Plaque removal efficacy of an advanced rotation-oscillation power toothbrush versus a new sonic toothbrush.

PURPOSE: To evaluate the plaque removal efficacy and safety of an advanced rotation-oscillation power toothbrush relative to a newly-introduced sonic toothbrush. METHODS: This study used a randomized, examiner-blind, two-treatment, four-period, four-sequence crossover design. Subjects received both toothbrushes (Oral-B Triumph and Sonicare FlexCare) and a standard dentifrice from the study site and used each toothbrush at home during an acclimation phase prior to their plaque measurement visits. After abstaining from all oral hygiene for 24 hours, subjects returned to the study site and were assessed with the Rustogi Modified Navy Plaque Index. They then brushed for 2 minutes with their first randomly-assigned toothbrush and post-brushing plaque scores were recorded. This procedure was followed for three additional study visits, with subjects using their normal at-home toothbrush and dentifrice for the 2- to 5-day washout periods between visits. Subjects always abstained from all oral hygiene for 24 hours prior to their visits. RESULTS: 45 subjects completed the study. Both brushes were found to be safe and both significantly reduced plaque after a single brushing. Oral-B Triumph was statistically significantly (P < 0.0001) more effective in plaque removal than Sonicare FlexCare for whole mouth plaque scores, gingival marginal plaque scores and interproximal plaque scores. Compared to Sonicare FlexCare, the adjusted mean plaque reduction scores for Oral-B Triumph were 21%, 23% and 22% greater for whole mouth, marginal and interproximal areas, respectively.

A clinical evaluation of extrinsic stain removal: a rotation-oscillation power toothbrush versus a dental prophylaxis.

AIM: To assess extrinsic stain removal efficacy of a power toothbrush and a dental prophylaxis followed by the use of a standardized American Dental Association (ADA) reference manual toothbrush. METHODS AND MATERIALS: This was a randomized, positive-controlled, examiner-blind, parallel group, two-week study. A Lobene stain examination was performed at baseline. Subjects were randomized to one of two treatment groups: Group 1: Oral-B Vitality Pro White power toothbrush or Group 2: Subjects receiving a dental prophylaxis then using a standardized ADA reference manual toothbrush. Subjects were instructed to brush their teeth with the assigned toothbrush and a fluoride dentifrice in front of a mirror twice per day for 2 minutes. Stain was reassessed following 2 weeks of brushing. RESULTS: A significant reduction (p <0.001) in mean Lobene composite scores after 2 weeks was found for Group 1 (90.6%) and Group 2 (94.4%). Both groups also showed a significant reduction (p <0.001) in extent and intensity scores. There was no significant group difference in reduction in mean Lobene composite scores (p>0.1). CONCLUSIONS: The Oral-B Vitality Pro White power toothbrush showed effective stain removal at a level similar to receiving an oral prophylaxis followed by the use of an ADA reference manual toothbrush. CLINICAL SIGNIFICANCE: In this small study the Oral-B Vitality Pro White power toothbrush achieved statistically significant stain removal between dental visits.

Clinical evaluation of the effects of a sonic toothbrush with ultrasound waveguide in disrupting plaque with and without bristle contact.

PURPOSE: To assess the in vivo plaque removal efficacy of the newly marketed sonic/ultrasonic toothbrush. Plaque removal resulting from the toothbrush being held approximately 3 mm from the tooth surface was compared versus a no brushing control. Also, plaque removal resulting from the brush being used according to the manufacturer's instructions was compared versus a control of using the brush (with power turned off) like a manual toothbrush would be used. METHODS: This was a replicate use, four-treatment, examiner-blind, randomized, eight-period crossover design single brushing plaque study involving 31 subjects. The four treatment regimens consisted of (1) brushing for 2 minutes with the Ultreo powered toothbrush according to manufacturer's instructions, (2) brushing for 2 minutes with the Ultreo toothbrush (power turned off) using the brush like a manual toothbrush, (3) having a trained dental hygienist hold the Ultreo toothbrush head 3 mm from tooth surfaces for a total of 2 minutes, or (4) swishing with a dentifrice slurry for 1 minute in the absence of toothbrushing. For each subject, an experienced, calibrated plaque examiner performed the Turesky Modified Quigley-Hein Plaque Index prior to brushing and following brushing. The difference (baseline minus post-regimen) in average scores was calculated for each subject. The difference scores were analyzed for treatment regimen differences using a mixed model ANCOVA (with baseline whole-mouth average score as the covariate and subjects considered random) for a crossover design. RESULTS: Adjusted mean plaque removal scores (baseline plaque score minus post-brushing plaque score) were 0.052 for swishing with a dentifrice slurry, 0.058 for the dental hygienist holding the Ultreo toothbrush approximately 3 mm from tooth surfaces, 0.536 for the Ultreo toothbrush used according to manufacturer's instructions and 0.666 for the Ultreo toothbrush (power turned off) used like a manual toothbrush. The difference between the Ultreo toothbrush held approximately 3 mm from tooth surfaces and swishing with a dentifrice slurry was not statistically significant (P = 0.808). The adjusted mean plaque removal score for the Ultreo toothbrush (power turned off) used like a manual toothbrush was statistically significantly (P < 0.001) greater than the corresponding score for the Ultreo toothbrush used per manufacturer's instructions. Ultreo used like a manual toothbrush had an adjusted mean plaque removal score that was 12.4% greater than that for Ultreo used per manufacturer's instructions. Finally, plaque removal scores for the Ultreo toothbrush used per manufacturer's instructions and used like a manual toothbrush were statistically significantly (P < 0.001) greater than plaque removal scores for the non-brushing treatment regimens.

Improved plaque removal efficacy with a new manual toothbrush.

AIM: To compare the safety and efficacy of two manual toothbrushes, Oral-B Exceed and Asian Colgate 360 masculine, in removing plaque. METHODS AND MATERIALS: The study used an examiner-blind, two-treatment, randomized, four-period (visits) crossover design. At the first visit, subjects received a baseline plaque examination; plaque was scored using the Rustogi et al. Modified Navy Plaque Index (RMNPI) and the Turesky et al. Modified Quigley-Hein Plaque Index (TQHPI). Subjects used their assigned toothbrush for one minute. Post-brushing plaque was assessed. The following three visits were separated by an interval of two to six days. At each visit, subjects were assigned brushes according to their treatment sequence and plaque was scored per the first visit. RESULTS: Forty-eight subjects were enrolled in the study; 47 were included in the analysis. Both brushes were found to be safe and both significantly reduced plaque after a single brushing. The Oral-B Exceed was significantly (p<0.001) better than the Asian Colgate 360 masculine at removing whole mouth plaque (18.1% using TQHPI; 9% using RMNPI). The Oral-B Exceed was also significantly better at removing marginal (p=0.001) and approximal (p=0.022) plaque. CONCLUSION: The Oral-B Exceed brush removed significantly more whole mouth, approximal, and gingival margin plaque than the Asian Colgate 360 masculine in a four-period crossover clinical comparison.

Plaque-removal efficacy of four types of dental floss.

BACKGROUND: Effective plaque removal is essential for gingival health, and dental floss is used to augment plaque removal achieved with a toothbrush. METHODS: This randomized, controlled, examiner-masked, five-period crossover study examined plaque removal in 25 subjects following single use with an American Dental Association reference manual toothbrush alone and in combination with four floss products: three traditional (unwaxed, woven, and shred-resistant) and one powered flosser. Plaque was scored before and after brushing for 1 minute. The Rustogi modified Navy plaque index was used to focus scores on tooth areas contacted during the proper use of dental floss. RESULTS: Mean plaque reductions (baseline minus postbrushing) in floss contact areas were as follows: 0.181 with the toothbrush alone; 0.228, 0.217, and 0.210 for the toothbrush in combination with the three traditional flosses, unwaxed, woven, and shred-resistant, respectively; and 0.252 for the toothbrush plus powered flosser. No statistically significant differences were found between the three traditional floss treatments. All four floss treatments showed greater (P <0.05) mean plaque removal than the toothbrush alone. Mean plaque removal with the powered flosser combination was greater than for the woven combination and shred-resistant combination (both P < or =0.006) and fell just short of significance compared to the unwaxed combination (P = 0.051). CONCLUSIONS: All four floss products in combination with a manual toothbrush removed plaque significantly better than the toothbrush alone. Among floss types, there was evidence of superiority for the powered flosser, but there were no significant treatment differences between the three traditional floss products.

A comparative clinical study of the plaque removal efficacy of an oscillating/rotating power toothbrush and an ultrasonic toothbrush.

OBJECTIVE: To evaluate the safety and efficacy of two power toothbrushes in the removal of dental plaque following a single brushing. METHODS: The study employed a two-treatment, examiner-blind, randomized, four-period crossover design. A total of 25 generally healthy adult subjects were enrolled into the study. Test products were an oscillating/rotating power toothbrush (Oral-B Triumph Professional Care 9000) and a newly marketed sonic toothbrush with an ultrasound waveguide (Ultreo). Subjects used each power toothbrush twice during the study following each manufacturer's usage instructions. Clinical examinations using the Turesky Modified Quigley-Hein Plaque Index (TMQHPI) as the primary variable and the Rustogi Modification of the Navy Plaque Index (RMNPI) were performed by calibrated and experienced clinical examiners prior to and following brushing. The difference (baseline minus post-regimen) in average plaque scores was calculated for each subject. The different scores were analyzed for treatment regimen differences using a mixed model analysis of covariance (with baseline whole-mouth average score as the covariate and subjects considered random) for a crossover design. RESULTS: Baseline whole-mouth TMQHPI and RMNPI plaque scores were well balanced between the two treatment groups. Adjusted mean whole-mouth TMQHPI plaque removal (baseline minus post-brushing) scores were 0.604 for the Triumph toothbrush and 0.488 for the Ultreo toothbrush. The Triumph toothbrush provided statistically significantly more plaque reduction that was 23.9% greater than the Ultreo toothbrush (p = 0.0001). The RMNPI examiner detected similar treatment differences in favor of the Triumph toothbrush, with a 16.3% greater plaque reduction than the Ultreo toothbrush (p < 0.0001). Both products were well tolerated with no adverse events reported in the study. CONCLUSION: The results demonstrate superior plaque removal efficacy of the oscillating/rotating Triumph toothbrush versus the Ultreo ultrasonic toothbrush.

Effect of an oscillating rotating power toothbrush on plaque removal and regrowth.

PURPOSE: To measure the effectiveness of an oscillating rotating power toothbrush as compared to a manual toothbrush. METHODS: 17 subjects were preliminarily assigned commercial tubes of Crest Cavity Protection (CCP) dentifrice and an Oral-B manual toothbrush (P35) with instructions for bid brushing morning and evening. Subjects remained on CCP dentifrice for 2 weeks during which they were imaged on 6 days (three each week) including daily assessments of morning plaque levels before brushing (AM), morning plaque levels after brushing (PB) and afternoon plaque levels allowing for regrowth (PM). Plaque was evaluated using standardized UV imaging techniques [Digital Plaque Image Analysis (DPIA) methodology]. At Week 3, subjects replaced their manual brush with an oscillating rotating power toothbrush (Oral-B Triumph) and were supplied with a detailed instruction/training video to assist in education and compliance with the power brush regimen. Plaque was evaluated during Week 3 on three additional days with measures again including AM, PB and PM. Throughout, plaque results are reported as average plaque area coverage on dentition. RESULTS: AM: Manual (2 week avg. +/- SD): 18.7 +/- 8.8; Power = 10.3 +/- 3.3 (44.9% relative reduction P < 0.05); PB: Manual (2 week avg.): 8.5 +/- 4.2; Power 4.6 +/- 1.9 (45.9% relative reduction P < 0.05); PM: Manual (2 week avg.): 14.9 +/- 6.4; Power = 8.2 +/- 3.1 (45.0% relative reduction P < 0.05).

Tooth whitening through the removal of extrinsic stain with two sodium hexametaphosphate-containing whitening dentifrices.

PURPOSE: To evaluate the tooth whitening benefit through stain removal delivered by a marketed whitening dentifrice (Crest Vivid White) used twice a day or a combination regimen of two marketed dentifrices (Crest Vivid White Night used at night and Crest Cavity Protection used in the morning) relative to a positive control over a 2-week period. METHODS: Both studies were randomized, two treatment, parallel group, examiner-blind, 2-week clinical trials involving 22 and 30 healthy adults with longstanding visible extrinsic stain on the facial surfaces of at least six anterior teeth. In each study, subjects were randomized to one of two treatments: a sodium fluoride/sodium hexametaphosphate whitening dentifrice used alone (Study 1) or in combination with a cavity protection dentifrice (Study 2) with an ADA reference manual toothbrush versus a control power toothbrush with a cavity protection dentifrice (both studies). RESULTS: In both studies, all treatment groups statistically significantly (P < 0.001) reduced baseline stain scores following 1 and 2 weeks of brushing. After 2 weeks, the whitening dentifrice used twice daily had a median percent stain removal of 90% and the night-time whitening dentifrice (used once a day) in combination with the cavity protection dentifrice had a median percent stain removal of 85% while powered toothbrush groups showed median percent stain removal of 88-89% in both studies. Stain removal scores after 1 and 2 weeks of brushing did not differ significantly between the two treatment groups in either study.

Comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the prevention of periodontitis in xerostomic patients: a 2-year randomized clinical trial.

BACKGROUND: The primary objective of this study was to compare the efficacy of a stannous fluoride (SnF2) dentifrice relative to a positive control triclosan dentifrice for prevention of clinical attachment loss (CAL) in xerostomic patients. A secondary objective was to compare the dentifrices for root caries remineralization. METHODS: This was a 2-year, randomized, double-masked, parallel-group study. A 0.454% SnF2/sodium hexametaphosphate dentifrice was tested versus a positive control dentifrice (sodium fluoride/0.30% triclosan/copolymer) in 440 medication-induced xerostomic adults identified in a 1-year, run-in phase (no treatment) as high risk for periodontitis and root caries. During the study phase, subjects were stratified based on gender and attachment level into two groups. Subjects brushed twice a day for 60 seconds using their assigned product. Clinical examinations including probing depth, attachment level, bleeding on probing, and root caries remineralization were performed at baseline and 1 and 2 years. RESULTS: A total of 334 subjects were evaluable. During run-in, average CAL relative to initial examination was 1.33 mm. Probing depth increased 0.95 mm. At year 2 in the treatment phase, attachment gain was 0.77 mm for the test group and 0.79 mm for the control group versus baseline. Probing depth decreased 0.57 mm for the test group, similar to the control group (0.53 mm). These changes versus baseline were statistically significant (P <0.01) for each group. Products were not statistically significantly different from each other. Both treatments resulted in similar remineralization for root caries lesions at study completion (P = 0.40). CONCLUSION: The results establish comparable benefits for the SnF2 dentifrice in preventing CAL and root caries versus the sodium fluoride/triclosan/copolymer control in xerostomic patients.

A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis.

OBJECTIVES: This study was conducted to assess anti-plaque and anti-gingivitis benefits of a stabilized stannous fluoride (SnF(2))/sodium hexametaphosphate (SHMP) dentifrice versus a negative control. MATERIAL AND METHODS: This was a randomized, 6-month, stratified, single-centre, double-blind, parallel group, clinical study conducted in harmony with the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% SnF(2)/SHMP dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were instructed to brush twice daily for 60 s using their assigned product. Efficacy measurements were obtained at baseline, 3 and 6 months post treatment using the Modified Gingival Index, Gingival Bleeding Index and the Turesky Modified Quigley-Hein Plaque Index. Oral tissue examinations were performed at all visits. RESULTS: A total of 140 subjects were enroled and 128 completed the study. RESULTS after 6 months showed the SnF(2) dentifrice delivered a 16.9% reduction in gingivitis (p<0.001), a 40.8% reduction (p<0.001) in gingival bleeding, and an 8.5% reduction in plaque (p=0.001) versus the negative control. Both treatments were well tolerated. CONCLUSIONS: Twice daily use of the SnF(2)/SHMP dentifrice over 6 months provided statistically significant anti-plaque and anti-gingivitis benefits relative to a negative control.

Extrinsic stain removal efficacy of a stannous fluoride dentifrice with sodium hexametaphosphate.

OBJECTIVE: Two randomized, six-week, double-blind, parallel group, clinical trials were independently conducted to compare the extrinsic stain removal efficacy of a novel whitening therapeutic dentifrice containing 0.454% stannous fluoride and sodium hexametaphosphate in a formulation with high cleaning silica, relative to a positive control whitening dentifrice. METHODOLOGY: Generally healthy adults, 56 for study 1 and 60 for study 2, with visible extrinsic tooth stain were enrolled in the studies. At the baseline visit, stain was assessed on the facial surfaces of the eight central and lateral incisors using the modified Lobene Stain Index. Oral soft and hard tissue examinations were also conducted. In each study, subjects were randomized to either the stannous fluoride + sodium hexametaphosphate toothpaste (Crest Pro-Health) or the positive control toothpaste (Colgate Total Plus Whitening) to use twice per day for six weeks. Stain and safety were reassessed at weeks three and six. RESULTS: Fifty-two and 58 subjects completed studies 1 and 2, respectively. In each study, there were no statistically significant differences in Lobene composite stain scores between the two treatment groups across all three visits. Both groups showed statistically significant reductions in Lobene composite stain scores at week three (p < 0.0001) and week six (p < 0.0001) relative to baseline. The percent of Lobene composite scores with a greater than 0.5 unit reduction from baseline at week six was 86% for study 1 and 97% for study 2 for the stannous fluoride + sodium hexametaphosphate dentifrice group. CONCLUSION: Collectively, these two stain removal clinical trials demonstrate the statistically significant extrinsic stain removal efficacy for the stannous fluoride + sodium hexametaphosphate dentifrice relative to baseline. There were no statistically significant differences between the stannous fluoride + sodium hexametaphosphate dentifrice and positive control treatment group.

Clinical evaluations of plaque removal efficacy: an advanced rotating-oscillating power toothbrush versus a sonic toothbrush.

OBJECTIVE: To evaluate the safety and plaque removal efficacy of an advanced rotating-oscillating power toothbrush relative to a sonic toothbrush with either a standard or compact brush head. METHODOLOGY: Two studies used a randomized, examiner-blind, two-treatment, crossover design. In Study 1, subjects were instructed to use their first randomly assigned toothbrush for five to seven days and then, after abstaining from all oral hygiene for 24 hours, were assessed with the Rustogi, et al. Modified Navy Plaque Index. They then brushed for two minutes and post-brushing plaque scores were recorded. Subjects were assigned to the alternate toothbrush and the procedures were repeated. In Study 2, subjects alternated using both brushes for approximately 10 days, then had four study visits three to four days apart (some variability based on patient scheduling). In Study 1, Oral-B Triumph with a FlossAction brush head and Sonicare Elite 7300 with a full-size, standard head were compared in a two-treatment, two-period crossover study. Study 2 compared Oral-B Triumph with a FlossAction brush head and Sonicare Elite 7300 with a compact head in a two-treatment, four-period crossover study. RESULTS: Fifty subjects completed Study 1 and 48 completed Study 2. All brushes were found to be safe and significantly reduced plaque after a single brushing. In Study 1, Oral-B Triumph was statistically significantly (p < 0.001) more effective in plaque removal than Sonicare Elite 7300 with the full-size brush head: whole mouth = 24% better, marginal = 31% better, approximal = 21% better. In Study 2, Oral-B Triumph was statistically significantly (p < 0.001) more effective than Sonicare Elite 7300 with the compact brush head: whole mouth = 12.2% better, marginal = 14.6% better, approximal = 12% better. CONCLUSION: Oral-B Triumph with its rotation-oscillation action was significantly more effective in single-use plaque removal than Sonicare Elite 7300 with its side-to-side sonic action when fitted with either a standard or a compact brush head.

Oral hygiene regimens, plaque control, and gingival health: a two-month clinical trial with antimicrobial agents.

OBJECTIVE: The purpose of this study was to examine the effects of various product combinations involving brush, paste, rinse, and floss on the prevention of plaque regrowth and gingivitis. METHODOLOGY: In this randomized, parallel-group, examiner-blind, eight-week study, 179 subjects with gingivitis had a dental prophylaxis and were randomly assigned to one of six product combinations: 1) Colgate Wave manual toothbrush + Colgate Total dentifrice (0.3% triclosan/copolymer dentifrice); 2) Wave + Total + Listerine (essential oils rinse); 3) Oral-B CrossAction manual toothbrush + Crest Pro-Health dentifrice (0.454% stannous fluoride/sodium hexametaphosphate); 4) CrossAction + Pro-Health dentifrice + Crest Pro-Health Rinse (0.07% cetylpyridinium chloride rinse); 5) Oral-B ProfessionalCare Series 8000 power toothbrush + Pro-Health dentifrice; or 6) ProfessionalCare power brush + Pro-Health dentifrice + Oral-B Hummingbird power flosser. Subjects used their test products for the duration of the study. Whole mouth plaque, gingivitis, and product-related adverse events were assessed. Treatments were compared at a 0.05 level of significance. RESULTS: One-hundred and seventy-four subjects completed the study and were included in the data analysis. At Week 8, the overnight adjusted whole mouth plaque scores were statistically significantly lower in all other groups relative to the Wave + Total group (p < or = 0.030). Plaque scores were also statistically significantly lower (approximately 20%) in both groups where a therapeutic rinse was added to a manual brush and therapeutic paste relative to scores for the brush plus paste without a rinse (p < or = 0.034). All groups showed a reduction in gingivitis at Week 4, and mean scores remained stable or increased slightly at Week 8. The power toothbrush groups were directionally better at preventing gingivitis than the manual groups at Weeks 4 and 8. CONCLUSION: Reductions in overnight plaque were seen when therapeutic rinses were added to manual brush plus therapeutic dentifrice regimens above that observed with a manual brush and therapeutic dentifrice alone.

Comparative plaque removal efficacy of a dual-action power toothbrush and a manual tooth: effects by tooth type.

PURPOSE: To evaluate the plaque removal efficacy of a dual action power toothbrush (Crest SpinBrush Pro Clean) relative to an ADA reference manual toothbrush. In addition to overall plaque removal, emphasis was put on plaque reduction around the gingival margin, interproximal areas of the tooth and in the posterior segment of the dentition. METHODS: The study was a randomized, examiner-blind, two-treatment, four-period, crossover design. After an informed consent, 50 healthy volunteers were randomized to four treatment sequences and used each toothbrush twice according to their assigned treatment sequence. At every visit, plaque removal was assessed at baseline and after a single brushing using the Rustogi-modified Navy Plaque Index that allows estimation of interproximal plaque and plaque at the gingival margin. Self-reported and examiner-observed adverse events were collected at every visit. Mean Plaque Index (MPI) scores were calculated for the whole mouth, gingival region, interproximal region and different areas of the dentition using an analysis of covariance for crossover design with baseline plaque score as the covariate. RESULTS: 49 subjects provided complete data and were included in the analysis. Baseline MPI scores were not significantly different between the groups for any investigated tooth region or dentition area. Following a single brushing, the power toothbrush provided a reduction of 43% (P< 0.001) for the whole mouth MPI, 43% (P< 0.001) for the gingival margin MPI and 65% (P< 0.001) for the interproximal MPI relative to a manual brush. Use of the power toothbrush resulted in a significant reduction of whole-mouth and gingival margin MPI across all areas of the dentition compared to a manual toothbrush (P< 0.001). The power toothbrush also had superior interproximal plaque removal efficacy compared to the manual toothbrush for molars (P< 0.001, with 118% greater removal score). Both brushes were well tolerated.

Relative plaque removal of three toothbrushes in a nine-period crossover study.

BACKGROUND: This study measured the ability of three toothbrushes to remove plaque following three single brushing episodes with each toothbrush. METHODS: This was a randomized, controlled, examiner-blind, nine-period crossover study conducted in 72 adult subjects over a 3-month period that examined plaque removal with a rechargeable power toothbrush and two manual toothbrushes. During the course of this study, subjects brushed three times with each of the toothbrushes. Plaque was scored before and after brushing using the Rustogi Modification of the Navy Plaque Index. RESULTS: Average baseline plaque scores were between 0.373 and 0.376 for the three treatment groups. The power toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.270, whereas the manual toothbrushes delivered adjusted mean differences of 0.211 (control ADA manual toothbrush) and 0.190 (experimental manual toothbrush). The power toothbrush demonstrated a statistically significantly greater reduction in plaque than the ADA reference manual toothbrush (P < 0.001), which in turn had a statistically significantly greater reduction in plaque than the experimental manual toothbrush (P < 0.001). The powered toothbrush group had, on average, 42.4% and 28.2% greater plaque removal scores than the experimental manual toothbrush and ADA reference manual toothbrush groups, respectively. Results for the interproximal and gingival regions also demonstrated statistically significantly (P < 0.001) greater plaque removal for the powered toothbrush relative to the control manual toothbrushes. CONCLUSION: The powered toothbrush was found to deliver greater plaque removal by 42.4% and 28.2% compared to the control manual toothbrushes.

Plaque removal efficacy of a prototype manual toothbrush versus an ADA reference manual toothbrush with and without dental floss.

OBJECTIVE: The objective of this study was to compare the plaque removal efficacy of a prototype manual Deep Clean toothbrush versus an American Dental Association (ADA) manual toothbrush and the ADA manual toothbrush in conjunction with floss. METHODS: This study was a randomized, examiner-blind, six-period cross-over, single-center study conducted in 60 adult subjects that examined plaque removal with a prototype Deep Clean manual toothbrush, an ADA reference manual toothbrush, and an ADA reference manual toothbrush followed by floss. During the course of this study, subjects used each treatment two times. Plaque was scored before and after brushing using the Rustogi Modification of the Navy Plaque Index. A mixed model analysis of covariance (ANCOVA) for a crossover design with baseline plaque score as the covariate was applied to the baseline minus one-minute post-brushing differences in average whole-mouth plaque scores. Supplemental analyses were also performed using the ANCOVA model separately for average gingival margin scores and for average interproximal scores, using the appropriate baseline score as the covariate. All comparisons were two-sided at the 0.05 level of significance. RESULTS: The prototype Deep Clean manual toothbrush delivered an adjusted (via ANCOVA) mean difference between baseline and post-brushing plaque scores of 0.245, while the ADA manual toothbrush plus floss delivered an adjusted mean difference of 0.207 versus 0.196 for the ADA manual toothbrush alone. The prototype Deep Clean manual toothbrush demonstrated a statistically significantly greater reduction in plaque than the ADA manual toothbrush plus floss (p<0.001), which in turn had a statistically significantly greater reduction in plaque than the ADA manual toothbrush alone (p<0.001). The prototype Deep Clean manual toothbrush group had, on average, 25.2% and 18.3% greater plaque removal scores than the ADA manual toothbrush alone and the ADA manual toothbrush plus floss groups, respectively. Results for the interproximal and gingival margin regions also demonstrated statistically significantly (p<0.001) greater plaque removal for the prototype Deep Clean manual toothbrush group relative to the other groups. CONCLUSIONS: The prototype manual Deep Clean toothbrush was found to deliver greater plaque removal by 25.2% and 18.3% compared to the control manual toothbrush group (ADA reference manual toothbrush) and ADA manual toothbrush plus floss group.

Plaque removal efficacy of a prototype power toothbrush compared to a control manual toothbrush.

PURPOSE: To compare the plaque removal efficacy of a control manual toothbrush (Lion Dentor Systema) to this prototype power toothbrush (Blend-a-Med Power) following a repeated single use study design. In addition, this paper reports the results of a study examining the relative plaque removal efficacy of the control manual toothbrush to nine representative manual toothbrushes. METHODS: This study was a randomized, controlled, examiner-blind, 6-period crossover design which examined plaque removal with the two toothbrushes following a single use in 86 completed subjects. Plaque was scored before and after brushing using the Turesky Modification of the Quigley-Hein Index. A second 10-period crossover study was conducted to index the relative plaque removal performance of the control manual toothbrush (Lion Dentor Systema) to nine representative manual toothbrushes. RESULTS: Baseline plaque scores were 2.322 and 2.305 for the prototype power toothbrush and control toothbrush treatment groups, respectively. With respect to all surfaces examined, the prototype power toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.633 while the control toothbrush delivered an adjusted mean difference of 0.576. The experimental toothbrush group, on average, had a 9.9% larger plaque removal score than the control toothbrush. These results were statistically significant (P= 0.014). Similar results were observed on buccal and lingual surfaces. In addition, results from the study comparing manual toothbrushes showed that the control manual toothbrush had similar plaque removal scores, not statistically significantly different, relative to nine representative manual toothbrushes.

Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice.

OBJECTIVE: Stannous fluoride is a broad-spectrum anti-microbial agent that has been used in dentistry as a chemical adjunct to prevent dental caries and gingivitis. The objective of this study was to assess the anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice relative to a negative control. METHODS: This was a randomized, 6-month, double-blind, parallel-group gingivitis study conducted according to the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 s using their assigned product. Oral soft-hard-tissue examinations and clinical examinations using the Modified Gingival Index, Gingival Bleeding Index, and the Turesky modification of the Quigley-Hein Plaque Index were performed at baseline, 3 and 6 months post-treatment. RESULTS: A total of 143 subjects were enrolled and 130 of them completed the 6-month study. After 6 months of product usage, the experimental group had 21.7% less gingivitis (p<0.001), 57.1% less bleeding (p<0.001), and 6.9% less plaque (p=0.01) on average compared with the negative control group. No adverse oral soft-hard-tissue effects or extrinsic tooth staining was observed in the study. CONCLUSION: The results demonstrate that use of the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 6-month period provided statistically significant reductions in gingivitis, gingival bleeding, and plaque when compared with a negative control dentifrice.