Clinical effectiveness of a dentifrice containing triclosan and a copolymer for controlling breath odor.

PURPOSE: To investigate in a double-blind clinical study the effectiveness of a dentifrice containing triclosan and a copolymer (Colgate Total Toothpaste) for controlling breath odor 12 hours after brushing the teeth. METHODS: A panel of four expert judges using a nine-point hedonic scale evaluated breath odor. Following a baseline evaluation of breath odor, prospective study subjects who presented breath odor scores above the threshold value for unpleasant breath odor were stratified by score, and randomized into two treatment groups. Subjects were provided with a soft-bristled toothbrush, and brushed their teeth thoroughly in their regular and customary manner with their assigned dentifrice. Subjects refrained from dental hygiene, breath mints, or mouthrinses for the next 12 hours, after which they were once again evaluated for breath odor. 76 adult male and female subjects from the Mississauga, Ontario, Canada area participated in the study. RESULTS: At 12 hours after brushing their teeth, subjects in both dentifrice treatment groups presented mean breath odor scores which were statistically significantly lower than the mean scores observed at baseline. However, the difference between the mean 12-hour breath odor score for the Colgate Total group was 4.65, which is within the range of values corresponding to pleasant breath odor; whereas the mean 12-hour breath odor score for the placebo group was 6.11, which is above the threshold value corresponding to unpleasant breath odor. Thus, the results of this double-blind study, conducted according to Guidelines by the Council on Scientific Affairs of the American Dental Association, support the conclusion that Colgate Total dentifrice provides effective control of breath odor at 12 hours after brushing the teeth.

Plaque removal efficacy and safety of the next generation of manual toothbrush with angled bristle technology: results from three comparative clinical studies.

PURPOSE: To investigate the safety and efficacy of a novel angled-bristled toothbrush in comparison with three established brushes. METHODS: The Oral-B CrossAction Vitalizer toothbrush was compared with two manual toothbrushes, the Oral-B CrossAction and Oral-B Advantage, and the battery-operated Crest SpinBrush Pro brush in three independent single-use, examiner-blind, crossover studies. In each study, over 50 healthy subjects from a normal population brushed with their randomly assigned toothbrush for 1 minute without instruction. Subjects returned after a 1-week washout period and brushed with the alternate toothbrush. At each visit, oral hard and soft tissues and plaque were examined before and after brushing. Plaque was evaluated using the Rustogi Modified Navy Plaque Index. RESULTS: Each tested toothbrush significantly (P=0.0001) reduced plaque levels after a single brushing. However, in all three studies, the CrossAction Vitalizer was significantly (P=0.0001) more effective than the comparator brushes in plaque removal from the whole mouth, the gingival margin and approximal surfaces. All toothbrushes were found to be safe with no evidence of oral hard or soft tissue trauma.

Comparative tooth whitening and extrinsic tooth stain prevention efficacy of a new dentifrice and a commercially available tooth whitening dentifrice: six-week clinical trial.

OBJECTIVE: The objective of this six-week, examiner-blind clinical study was to assess the tooth whitening and extrinsic stain prevention efficacy of a new dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base (Test Dentifrice) relative to that of a commercially available hexametaphosphate-containing whitening dentifrice (Positive Control Dentifrice). METHODOLOGY: Following a baseline oral soft tissue examination and scoring of extrinsic tooth stain and tooth shade, qualifying adult male and female subjects from the Mississauga, Ontario, Canada area were randomized into either the Test or Positive Control Dentifrice group. The two groups were balanced for age, tobacco use, extrinsic tooth stain, and tooth shade scores. All subjects received a dental prophylaxis, and were provided with a supply of their assigned product and a soft-bristled adult toothbrush for use at home. Subjects were instructed to brush their teeth for two minutes twice daily (morning and evening) using only the dentifrice provided, and to refrain from using any other oral hygiene products for the entire six weeks of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Oral soft tissue, extrinsic tooth stain and tooth shade assessments for each subject were repeated after two and six weeks of product use. All statistical tests were two-sided and employed a level of significance of alpha = 0.05. RESULTS: Seventy-six (76) subjects complied with the protocol and completed the entire study. At both the two-week and six-week examinations, the Test Dentifrice prevented statistically significant (p < 0.05) more tooth stain as compared to the Positive Control Dentifrice. Also, at the two-week and six-week examinations, the Test Dentifrice provided statistically significant (p < 0.05) greater tooth whitening as compared to the Positive Control Dentifrice (2.64 and 3.77 shade rank reductions, respectively). CONCLUSION: A new whitening dentifrice, delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base provides a statistically significant greater level of efficacy for both tooth whitening and prevention of extrinsic tooth stain than the commercially available Positive Control Dentifrice.

The effect of two power toothbrushes on calculus and stain formation.

PURPOSE: To compare the safety and efficacy with respect to the control of calculus and stain of two power toothbrushes. MATERIALS AND METHODS: This was a cross-over study involving a total of 81 subjects from a general population who used, in a randomized sequence, the Braun Oral-B 3D Excel (D17) and the Sonicare toothbrush with a conventional dentifrice, and a manual brush with a tartar control dentifrice. The manual toothbrush with tartar control dentifrice served as a positive control with respect to control of calculus. Following 9 weeks of manual brush use with a conventional, non-abrasive dentifrice, each test brush was used for a period of 9 weeks, after which subjects switched to the next brush in the sequence. Calculus was scored using the Volpe-Manhold Calculus Index and stain using the Lobene Stain Index. RESULTS: All three brushes were found to be safe as used in the study. All three toothbrushes significantly reduced the levels of calculus as compared to the control period. Reduction from baseline in the rate of calculus formation was greatest in the D17 group (63%), followed by the manual brush with tartar control dentifrice (60%) and Sonicare (44%). Both the D17 and the manual brush were significantly more effective than Sonicare (P< 0.001). The D17 was also more effective at controlling stain formation than either Sonicare or the manual brush with tartar control dentifrice at the gingival margin, the difference from Sonicare being statistically significant for all analyses (P< 0.0001). It is concluded that the D17 is significantly more effective in reducing both the rate of calculus and stain formation than the Sonicare toothbrush.

The clinical efficacy of Colgate Total Plus Whitening Toothpaste containing a special grade of silica and Colgate Total Toothpaste for controlling breath odor twelve hours after toothbrushing: a single-use clinical study.

The objective of this double-blind clinical study, conducted in harmony with American Dental Association guidelines, was to compare a new dentifrice formulation variant of Colgate Total Toothpaste containing a special grade of silica (Colgate Total Plus Whitening Toothpaste) to the commercially available, ADA-Accepted and clinically proven Colgate Total Toothpaste for controlling breath odor twelve hours after brushing the teeth. Breath odor was evaluated by a panel of three examiners using a nine-point hedonic scale. Following a baseline evaluation of breath odor, prospective study subjects who scored above the threshold value for unpleasant breath odor were stratified by score and randomized into two treatment groups. Subjects were provided with a soft-bristled toothbrush, and brushed their teeth thoroughly in their regular and customary manner with their assigned dentifrice. Subjects refrained from dental hygiene, breath mints or mounthrinses for the next twelve hours, after which they were again evaluated for breath odor. Eighty-three (83) adult male and female subjects from the Mississauga, Ontario, Canada area participated in the study. At twelve hours after brushing their teeth, subjects in both dentifrice treatment groups presented mean breath odor scores which were statistically significantly lower than the mean scores observed at baseline. Importantly, there was no statistical difference between the two dentifrices of the mean twelve-hour breath odor scores. The mean twelve-hour breath scores for the Colgate Total Plus Whitening Toothpaste group and the Colgate Total Toothpaste group were 4.89 and 4.67, respectively, which are within the range of values corresponding to pleasant breath odor. Thus, the results of this double-blind clinical study, conducted according to a protocol which had been approved by the Council on Scientific Affairs of the American Dental Association, support the conclusion that Colgate Total Plus Whitening Toothpaste and Colgate Total Toothpaste provide effective control of breath odor at twelve hours after toothbrushing.

Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque.

PURPOSE: To compare the effectiveness of rinsing with an essential oil-containing antimicrobial mouthrinse with that of dental floss in reducing interproximal gingivitis and plaque in an unsupervised 6-month clinical trial designed in accordance with ADA Acceptance Program Guidelines. MATERIALS AND METHODS: 319 qualifying subjects, aged 18-63, were randomized into one of three groups: essential oil mouthrinse (Listerine Antiseptic); dental floss (Reach Dental Floss); or a negative control rinse. At baseline, subjects received a complete oral soft tissue examination and scoring of the Modified Gingival Index (MGI), modified Quigley-Hein Plaque Index (PI), and bleeding index (BI). Following a complete dental prophylaxis and receiving flossing or rinsing instructions, subjects started on their respective regimen. They continued on their assigned regimen unsupervised at home, in addition to toothbrushing, and were reexamined at 3 and 6 months. The treatment groups were compared with respect to baseline demographic and clinical variables. The primary efficacy variables were mean interproximal MGI and PI at 6 months. Intergroup differences at 3 and 6 months were tested using a one-way analysis of covariance model with treatment as a factor and the respective baseline value as the covariate. In addition, the essential oil mouthrinse was compared to floss for interproximal gingivitis reduction using "at least as good as" statistical criteria. RESULTS: 301 subjects were considered evaluable. There were no statistically significant differences among the 3 groups at baseline, with the exception of the essential oil mouthrinse group having significantly fewer AfroAmerican subjects than the other two groups. For the interproximal MGI, the essential oil mouthrinse and flossing were both significantly more effective than the negative control (P < 0.001) at 3 and 6 months. The essential oil mouthrinse was shown to be "at least as good as" dental floss for the control of interproximal gingivitis. For the interproximal PI, the essential oil mouthrinse was significantly more effective than the negative control at 3 and 6 months (P < 0.001) while flossing was significantly more effective than the negative control at 3 months (P < 0.05) but not at 6 months. The essential oil mouthrinse was significantly more effective than floss (P < 0.001) at both these time periods.