Comparative Plaque Removal Efficacy of Three Manual Toothbrushes.

OBJECTIVES: The purpose of this study was to determine the safety and plaque-reducing effectiveness of a newly designed manual toothbrush compared to that of a leading marketed toothbrush and a reference standard manual toothbrush control. METHODS: This examiner-blind, randomized, single-use study used a cross-over design. Sixty-eight qualifying male and female subjects were randomly assigned either an Arm & Hammer™ Truly Radiant™ Deep Clean manual toothbrush (TR), a Colgate® Extra Clean manual toothbrush (C), or an ADA reference standard manual toothbrush (SM) according to one of three computer-generated sequences. Following instruction in the use of their assigned brush, subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period. At the end of this period, the subjects returned to the study site after refraining from oral hygiene for 12-16 hours and from eating and drinking for four hours. Plaque was disclosed and scored using the Rustogi Modification of the Navy Plaque Index (RMNPI). Subjects brushed under supervision with their assigned toothbrush for two minutes in a room without mirrors and apart from the dental examiner, after which plaque was disclosed and rescored. They were then given one of the alternate toothbrushes according to their assigned sequence, and the familiarization routine and evaluations were repeated until each of the subjects used each of the three brushes. Within-treatment and between-treatment whole mouth RMNPI scores and scores at each of twelve subsets of sites were analyzed using paired t-tests and appropriate ANCOVA models, respectively. RESULTS: Within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth RMNPI scores (p < 0.0001), with respective reductions of 68.2%, 58.3%, and 48.5% for TR, C, and SM. Between-group analyses showed that TR was significantly more effective (p < 0.0001) than C and SM with 16.4% and 40.3% greater reductions in whole mouth scores, respectively. TR also produced statistically significant greater reductions (p < 0.0001) than the other two manual brushes at each of the twelve subsets of sites examined, with the greatest differences at the lingual and gingival sites, especially sites presenting difficulty in access, such as those in the posterior lingual gingival region. CONCLUSIONS: While all three manual toothbrushes produced significant supragingival plaque reductions with a single use, the Truly Radiant Deep Clean brush was significantly more effective than the Colgate Extra Clean and ADA manual brushes in reducing wholemouth plaque, as well as plaque at all subsets of sites analyzed including difficult-to-reach areas.

Comparative Plaque Removal Efficacy of a New Powered Toothbrush and a Manual Toothbrush.

OBJECTIVES: The purpose of this study was to determine the plaque removal effectiveness of a new powered toothbrush and compare it to that of a manual brush. METHODS: This examiner-blind, randomized study used a cross-over design. Sixty-two (62) qualifying subjects were randomly assigned either to the powered brush (Arm & Hammer Spinbrush™ Truly Radiant™ Clean & Fresh Battery-Powered Toothbrush), or a standard manual toothbrush (ADA Standard Manual Toothbrush) and instructed to brush at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period. At the end of this period, the subjects returned to the study site. After refraining from oral hygiene for 12-16 hours and from eating and drinking for four hours, plaque was disclosed by rinsing with an erythrosine dye solution and scored using the Rustogi Modification of the Navy Plaque Index (RMNPI). Subjects then brushed under supervision with their assigned toothbrush for two minutes, and plaque was disclosed and rescored. They were then given the alternate toothbrush, and the familiarization routine and evaluation process were repeated. The primary outcome variable was mean whole mouth RMNPI score with additional analyses performed on regional subsets of tooth surfaces. RESULTS: Within-group analysis showed that both toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores (p < 0.01), with respective whole mouth reductions of 40.7% and 24.9% for the powered brush and the manual brush. Between-group analyses showed that the powered brush produced a statistically significantly greater plaque reduction than the manual brush, both whole mouth (63.7%, p < 0.0001) and at all 12 subsets of sites. CONCLUSIONS: When evaluated using this single-use clinical model, the Arm & Hammer Spinbrush Truly Radiant Clean & Fresh powered toothbrush was statistically significantly more effective in reducing plaque than the manual toothbrush, both whole mouth and at all regional subsets of tooth surfaces, including difficult-to-reach sites.

Clinical Study to Determine the Stain Removal Effectiveness of a New Dentifrice Formulation.

OBJECTIVES: This randomized, prospective clinical trial was conducted to determine the safety and effectiveness of a new whitening dentifrice formulation in comparison to that of both a negative and a positive control dentifrice. METHODS: Seventy-nine qualifying subjects were randomly assigned to either the new whitening dentifrice (Arm & Hammer® Truly Radiant™ Clean & Fresh Toothpaste), a positive control whitening dentifrice (Crest® 3-D White® Radiant Mint Toothpaste), or a negative control regular dentifrice (Colgate® Cavity Protection Toothpaste). The subjects brushed with their assigned dentifrice for two minutes, twice daily, for five days. Extrinsic tooth stain was assessed using a Modified Lobene Stain Index (MLSI) at baseline and after five days of product use. RESULTS: All entering subjects completed the study. There were no significant differences (p > 0.05) in stain among the three groups at baseline. The Arm & Hammer Truly Radiant and positive control groups had statistically significant (p < 0.001) mean composite MLSI reduction scores of 13.2% and 7.8%, respectively, from baseline to day five. The negative control dentifrice group was virtually unchanged during this period. Intergroup comparisons showed the Truly Radiant group to have significantly greater stain removal (p < 0.0001) scores than the negative control. The Truly Radiant group also had greater stain removal than the positive control, though the differences were not statistically significant. CONCLUSIONS: This study demonstrates that five-days' use of Arm & Hammer Truly Radiant Clean & Fresh dentifrice was significantly more effective in stain removal than a regular (non-whitening) dentifrice and comparable in effectiveness to a whitening dentifrice positive control.

Clinical Effectiveness Evaluation of a New Whitening Dentifrice.

OBJECTIVE: This randomized controlled clinical trial was conducted to determine the effectiveness and safety of a new whitening dentifrice. METHODS: One hundred eighty-two qualifying subjects were randomly assigned to either a whitening dentifrice group (Arm & Hammer Truly Radiant Toothpaste), a negative control dentifrice group (Colgate Cavity Protection Toothpaste), or a positive control dentifrice group (Crest 3-D White Radiant Mint Toothpaste) and were instructed to brush twice daily with their assigned dentifrice for six weeks. Extrinsic tooth stain was assessed using a Modified Lobene Stain Index (MLSI) and tooth shade was assessed using the VITA Classic Shade Guide at baseline and after five days and two, four, and six weeks of dentifrice use. Safety was monitored by clinical examinations and panelist assessment at each evaluation period. RESULTS: The Arm & Hammer Truly Radiant group showed a statistically significant improvement from baseline in mean composite MLSI and VITA shade at each examination period (p < 0.0001). Significant improvements on day 5 progressively increased with increasing duration of product use. By week 6, there was a 45.4% reduction in stain and a 2.08 improvement in tooth shade. The between-group comparison revealed that Truly Radiant toothpaste was significantly more effective than both the negative and positive control dentifrices for these parameters (p < 0.0001) at each exam time. CONCLUSION: This study showed that the new dentifrice formulation is safe and effective on stain removal and tooth whitening.

Extrinsic Stain Removal Effectiveness of a New Whitening Dentifrice.

OBJECTIVE: This study was conducted to evaluate the effectiveness of Arm & Hammer (A&H) Truly Radiant Rejuvenating toothpaste in removing extrinsic tooth stain compared to that of a conventional fluoride/silica-containing dentifrice. METHODS: This was a randomized, examiner-blind, parallel-design study with two groups of subjects who brushed unsupervised with their assigned dentifrice for two minutes, twice daily, for five days. Extrinsic stain was measured on the labial surfaces of the eight incisor teeth by the Modified Lobene Stain Index (MLSI) at baseline and following five days of product use. After balancing for baseline MLSI, beverage and tobacco use, fifty-four healthy adults with existing stain were randomly distributed into two comparable groups: Arm and Hammer Truly Radiant Rejuvenating toothpaste or Colgate Cavity Protection toothpaste (negative control). Within-treatment comparisons between baseline and day five were made using matched-pair t-tests, and between-treatment comparisons of MSLI scores were performed using ANCOVA, with baseline scores as covariates. RESULTS: Twenty-eight subjects in the Truly Radiant Rejuvenating toothpaste group and twenty-six subjects in the negative control group completed the study. The groups had comparable mean scores at baseline (p > 0.05). The Truly Radiant Rejuvenating toothpaste produced a statistically significant 23.1% total (composite) stain reduction from baseline after five days of product use (p < 0.0001) while the negative control was essentially unchanged (p > 0.05). Between-treatment analysis showed statistically significantly (p < 0.0001) greater stain removal for Truly Radiant Rejuvenating toothpaste compared to the Colgate control following five days of product use. There were no adverse events reported during the study. CONCLUSION: The A&H Truly Radiant Rejuvenating toothpaste is safe and effective in reducing extrinsic stain compared to a regular toothpaste control.

Clinical Study to Assess the Stain Removal Effectiveness of a Tooth Whitening Regimen with Added Whitening Booster.

OBJECTIVE: This randomized, controlled clinical trial was conducted to assess the extrinsic stain reduction achieved by brushing with a whitening dentifrice and powered toothbrush, and to determine whether the addition of a whitening booster paste to this regimen would enhance its stain reducing effectiveness. METHODS: Sixty qualifying subjects were randomly assigned either to Regimen One, a whitening dentifrice (Arm & Hammer Truly Radiant [TR] toothpaste] and powered toothbrush (Arm & Hammer Truly Radiant [TR] Extra Whitening Spinbrush); Regimen Two, the dentifrice and powered toothbrush with the addition of a whitening booster; or Regimen Three, a negative control (Colgate Cavity Protection toothpaste and an ADA standard manual brush). They were instructed in the use of their assigned products and then brushed unsupervised at home for two minutes, twice daily, for 14 days. Extrinsic tooth stain was assessed at baseline and after two, five, and 14 days using a Modified Lobene Stain Index (MLSI) with Lobene inclusion criteria of ≥ 1.5. RESULTS: All three treatment groups had statistically significant (p < 0.0001) mean total MLSI reductions from baseline at each time point, in a time-dependent manner. Day 14 reductions were 22.2% for Colgate Cavity Protection, 29.1% for Regimen One, and 34.4% for Regimen Two. Reductions for Regimen One and Regimen Two were significantly greater compared to Regimen Three, the negative control, at each time period (p < 0.01), and those for Regimen Two were significantly greater compared to Regimen One on days 2 and 14 (p < 0.05) and directionally more effective on day 5 (p = 0.0673). CONCLUSION: The combination of Truly Radiant toothpaste and Truly Radiant Spinbrush provides safe and effective stain removal that can be further enhanced by the addition of the whitening booster.

Comparative plaque removal efficacy of two new powered toothbrushes and a manual toothbrush.

OBJECTIVE: The purpose of this study was to determine the plaque-reducing effectiveness of two new powered toothbrushes and compare them to a manual toothbrush control. METHODS: This examiner-blind, randomized study used a crossover design. Sixty-five qualifying male and female subjects were randomly assigned one of the two test powered brushes (Spinbrush Truly Radiant Deep Clean [TRDC] or Spinbrush Truly Radiant Extra Whitening [TREW], Church & Dwight Co., Inc., Princeton, NJ, USA) or an ADA standard manual toothbrush (MT; American Dental Association, Chicago, IL, USA) according to one of three computer-generated sequences. Following instruction in the use of their assigned toothbrush, subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period. At the end of this period, the subjects returned to the study site after refraining from oral hygiene for 12-16 hours, and from eating, drinking, and smoking for four hours. Plaque was scored using the Rustogi Modification of the Navy Plaque Index. Subjects brushed under supervision with their assigned toothbrush for two minutes, and plaque was rescored. They were then given one of the alternate toothbrushes according to their assigned sequence, and the familiarization routine and evaluation processes were repeated until each of the subjects used each of the three brushes. RESULTS: Within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores (p < 0.001), with respective whole mouth reductions of 17.9%, 42.3%, and 38.1% for MT, TRDC, and TREW. Between-group analyses showed that TRDC and TREW were each significantly more effective (p < 0.001) than MT, as each showed at least twice as much of a reduction in whole mouth scores. Both of the powered brushes also produced statistically significantly greater reductions than the manual brush at each of the twelve subsets of sites examined, with the greatest differences at interpoximal sites and sites presenting access difficulty, such as those in the lingual posterior region. Additionally, TRDC produced a statistically significant 11.5% greater reduction than TREW (p = 0.001) in whole mouth plaque scores, and statistically significantly greater reductions in two of the subsets evaluated. CONCLUSION: Both of the powered brushes tested proved to be safe and significantly more effective than the standard manual control brush in reducing plaque. While the finding that the TRDC was significantly more effective than the TREW in reducing whole mouth plaque and plaque in two subsets demonstrates that small differences in toothbrush design may impact performance, longer-term studies would be needed to assess the extent to which this translates to meaningful clinical outcomes.

Comparative plaque removal efficacy of a new children's powered toothbrush and a manual toothbrush.

OBJECTIVE: The purpose of this study was to determine the plaque removal effectiveness of a new children's powered toothbrush and compare it to that of a manual brush. METHODS: This examiner-blind, randomized study used a cross-over design. One-hundred and five qualifying male and female subjects (52 ages 8-12 and 53 ages 13-17) were randomly assigned either the powered brush (Spinbrush GLOBRUSH) or a manual toothbrush (Oral-B Indicator 30 Compact Soft Toothbrush) and instructed to brush at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period. At the end of this period, the subjects returned to the study site after refraining from oral hygiene for twenty-four hours and from eating and drinking for four hours. Plaque was scored using the Rustogi Modification of the Navy Plaque Index, subjects brushed under supervision with their assigned toothbrush for two minutes, and plaque was rescored. They were then given the alternate toothbrush and the familiarization routine and evaluation process were repeated. RESULTS: Within-group analysis showed that both toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores (p < 0.0001), with respective whole mouth reductions of 73.3% and 61.8% for the powered brush and the manual brush. Between-group analyses showed that the powered brush produced a statistically significantly greater plaque reduction than the manual brush, both whole mouth (12.8%, p < 0.0001) and at all subset sites, including difficult-to-reach areas such as the posterior lingual gingival region (74.9% greater plaque reduction, p < 0.0001). CONCLUSION: The Spinbrush GLOBRUSH was significantly more effective in reducing plaque than the manual toothbrush when evaluated using this single-use clinical model.

Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth.

OBJECTIVE: The primary purpose of this randomized, controlled, six-week clinical trial was to determine the effectiveness and safety of a new whitening dentifrice in removing extrinsic tooth stain and whitening teeth. An additional two-week exploratory study was conducted to determine whether the whitening or stain-prevention activity of the dentifrice would persist following cessation of use. METHODS: In the first study (Phase I), one-hundred and forty-six qualifying subjects were randomly assigned to either a sodium bicarbonate whitening dentifrice group (Arm & Hammer Advance White Extreme Whitening Baking Soda and Peroxide Toothpaste) or a silica-based negative control dentifrice group, and brushed twice daily with their assigned dentifrice for six weeks. Tooth shade on the labial surfaces of the eight incisors was assessed using a Vita Classic shade guide, and extrinsic tooth stain was scored using a Modified Lobene Stain Index (MLSI) at baseline, week 4, and week 6. In Phase II (after the week 6 examination), volunteers from the Arm & Hammer whitening dentifrice group were randomly assigned to continue using the whitening dentifrice or to use the negative control dentifrice twice daily for two weeks. The six-week shade and stain index scores served as the baseline for this exploratory phase and were rescored after two weeks. RESULTS: The whitening dentifrice group had statistically significant (p < 0.0001) mean shade score reductions of 1.82 and 2.57 from baseline to weeks 4 and 6, respectively. For the same periods, the negative control dentifrice group was virtually unchanged from baseline. For tooth stain, the MLSI total mean scores for the whitening dentifrice group showed statistically significant (p < 0.0001) decreases from baseline of 1.42 (41.6%) and 2.11 (61.6%) at weeks 4 and 6, respectively. In contrast, the negative control dentifrice group had a MLSI reduction of 0.07 at week 4 and a 0.06 increase at week 6. Between-group analyses using baseline-adjusted ANCOVA showed the whitening dentifrice to be statistically significantly more effective (p < 0.0001) than the negative control for shade and tooth stain reductions for all index comparisons. Compared to the six-week (baseline) scores, subjects who continued to use the whitening dentifrice for the additional two weeks experienced statistically significant (p < 0.0001) further mean reductions of 0.88 in shade score and 0.46 in MLSI score, while subjects who switched to the negative control dentifrice experienced smaller, statistically significant (p < 0.05) reductions of 0.34 in shade score and 0.13 in total MLSI score. CONCLUSION: The Arm & Hammer whitening dentifrice tested in this study is effective for removing extrinsic tooth stain and whitening teeth. While the results also suggest that this dentifrice may have stain-prevention activity that persists following cessation of product use, such activity would need to be confirmed with further studies.