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Purpose: To evaluate the efficacy of a novel multi-directional power toothbrush in reducing plaque and gingivitis relative to a standard manual toothbrush control., Methods: This 4-week, randomized and controlled, single-center, parallel group, examiner-blinded clinical study enrolled adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis and plaque levels were assessed via the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Subjects qualifying were assigned randomly to one of two toothbrush groups: a novel multi-directional power toothbrush (Oral-B Professional Deep Sweep TRICLEAN 1000, also marketed as Oral-B TriZone) or a standard soft manual control toothbrush. Aside from a supervised brushing at baseline on-site, subjects brushed at home twice daily with their assigned test brush. After 1 week, subjects returned for RMNPI plaque evaluations. At Week 4, subjects were again recalled to evaluate toothbrush efficacy, and received MGI and GBI gingivitis and RMNPI plaque evaluations., Results: 119 evaluable subjects completed the study. Both the novel power and manual control toothbrushes yielded statistically significant (P < 0.001) mean plaque reductions compared to baseline at Weeks 1 and 4 (except Week 1 manual brush gingival margin) and significant mean MGI and GBI gingivitis reductions (P < 0.001). Comparing the relative effectiveness of the test brushes, the novel multi-directional power brush produced significantly superior anti-gingivitis and anti-plaque reductions compared to pre-treatment relative to the manual control brush in every analysis at both time points. The Week 4 adjusted mean relative reductions favoring the multi-directional power brush were 3 and 1.49 times greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 2.1, 4.7 and 2 times greater for the RMNPI whole mouth, gingival margin and interproximal regions, respectively (P < 0.001). Both toothbrushes were well-tolerated.

Purpose: To compare the safety and efficacy of a novel sonic power toothbrush and a manual toothbrush in the reduction of gingivitis and plaque over a 4-week period., Methods: This study employed a randomized two treatment, examiner-blinded, parallel group design. Subjects with evidence of gingivitis were randomly assigned to 4 weeks' twice daily home use of either the Oral-B Pulsonic sonic toothbrush or an ADA reference manual toothbrush. At baseline (Visit 1) and again after product use at Week 4, subjects received gingivitis evaluations with the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) examinations, followed by plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI). For 12 hours before both visits, subjects abstained from all oral hygiene, and ceased eating, drinking and smoking 4 hours prior., Results: Both brushes significantly reduced gingivitis, gingival bleeding and plaque compared with baseline, and were well-tolerated by the 129 subjects completing the study. The sonic toothbrush was statistically significantly (P < 0.0001) more effective than the manual brush, with greater relative mean reductions in MGI, GBI and RMNPI of 11.9%, 62.3% and 46.5%, respectively.

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.

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.

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.

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.

Purpose: To compare the safety and plaque removal efficacy of a battery-operated power toothbrush and a reference adult manual toothbrush., Materials and Methods: This was a single-blind, randomized, split-mouth study. The power toothbrush studied was the Braun Oral-B Battery toothbrush (D4) and this was compared with a standard reference ADA manual toothbrush. The D4 toothbrush is derived from the Plaque Remover range of toothbrushes and has an oscillating/rotating action. At an initial visit, subjects (n = 48) were given a baseline examination of the oral hard and soft tissues and were instructed in the use of the D4. After one week during which subjects used the D4 at home, they returned to the test facility having abstained from oral hygiene for 23-25 hours. Two contralateral quadrants of the mouth were then randomly assigned to be cleaned with each toothbrush. Plaque assessments and hard and soft tissue examinations were made before and after brushing each quadrant for 15 seconds. Plaque was evaluated using the Rustogi modification of the Navy Plaque Index., Results: Plaque levels were significantly reduced for all sites, marginal sites and approximal sites by both toothbrushes (P < 0.0001), but the efficacy of the D4 was significantly greater than that of the ADA manual brush for all comparisons (P < 0.0001). The greatest difference between the two toothbrushes was at approximal sites where the D4 removed 19% more plaque than the manual toothbrush. For all sites, the D4 was 14% more effective, while at marginal sites the difference in favor of the D4 was 12%.

Purpose: To compare the clinical efficacy with respect to plaque removal of a battery-operated power toothbrush (Dr. Johns Spin Brush Classic) with two manual toothbrushes, a standard ADA flat trim reference brush and the Oral-B CrossAction toothbrush., Materials and Methods: Efficacy was evaluated in two independent studies using a randomized, single-use, cross-over design. Healthy adult subjects from a general population brushed their teeth for a timed 1 min and plaque was scored before and after brushing was completed. In Study 1 (Spin Brush vs. ADA toothbrush), plaque was scored using the modified Quigley and Hein Plaque Index, while in Study 2 (Spin Brush vs. CrossAction) plaque was scored using the Modified Navy Plaque Index. In addition, a hard and soft tissue examination was carried out before and after brushing to allow evaluation of safety., Results: In Study 1, both the ADA toothbrush and the Spin Brush significantly reduced levels of whole mouth and approximal plaque (P < 0.0005); however, the Spin Brush was not significantly more effective than the manual brush. Relative plaque reduction for the whole mouth was 35.6 +/- 16.0% for the Spin Brush compared to 38.9 +/- 14.9% for the manual toothbrush (P < 0.047), and, for the approximal surfaces, 32.7 +/- 14.6% and 36.3 +/- 13.7%, respectively (P = 0.024). In Study 2, both toothbrushes significantly reduced plaque levels (P < 0.0001), but, as for Study 1, the CrossAction manual toothbrush was more effective than the Spin Brush. For whole mouth, marginal and approximal sites, respectively, the Spin Brush reduced plaque by 54.3%, 43.5% and 62.0%, compared with 58.6%, 47.5% and 67.1% for the CrossAction toothbrush. The difference in favor of the CrossAction brush was statistically significant (P < 0.0005) for all areas.

Purpose: To assess the efficacy of two essential oil-containing dentifrices in the reduction of human intrinsic oral malodor ("morning bad breath")., Materials and Methods: Two clinical trials were conducted which used observer-blind, negative control, parallel designs. To insure a homogeneous test population with similar oral odor characteristics, subjects followed instructions that included toothbrushing with a standard ADA-accepted fluoride dentifrice the night before. On odor evaluation days, subjects refrained from all oral hygiene procedures and from eating or drinking any food or beverage or smoking prior to and during the odor evaluations. Eighty healthy adult subjects in the first trial and 90 in the second trial with qualifying baseline levels of oral malodor participated. Odor ratings of each subject's breath were made by 4-5 trained judges using a nine point hedonic scale, i.e., 1 = most pleasant, 5 = neutral, 9 = most unpleasant. Qualifying subjects were randomly assigned one of two essential oil dentifrices or a negative control dentifrice. Subjects brushed with their assigned dentifrice for 60 s, rinsed with 20 ml of water for 10 s, and received post-treatment hedonic odor ratings at 30, 60, 90, 120, 180, and 240 min. Data were analyzed using an ANCOVA to adjust for baseline scores., Results: The essential oil dentifrices were significantly more effective (P < or = 0.033) than the control in reducing intrinsic oral malodor from 90 to 120 min.

Purpose: To compare the efficacy of a new toothbrush featuring a novel brush head design with those of two established toothbrushes by measuring plaque and gingivitis over a period of 12 weeks., Materials and Methods: The Oral-B CrossAction toothbrush was compared with the Dr. Best InterDent and Crest DeepSweep toothbrushes in two independent, parallel-group, examiner-blind clinical studies. Each study involved approximately 100 healthy individuals from a general population. At baseline, after 23-25 hrs of no oral hygiene, oral hard and soft tissues were examined and whole mouth, marginal and approximal plaque scores and whole mouth gingivitis scores were recorded. Subjects in the two studies were asked to use their assigned toothbrush twice a day. No instruction in brushing technique or brushing time was given. After a period of 6 weeks and finally after 12 weeks, subjects in the studies were reassessed for oral tissue status, and their plaque and gingival indices were rescored., Results: In each of the two studies, the tested toothbrushes significantly reduced levels of plaque and gingivitis. The CrossAction toothbrush was, however, more effective in reducing both plaque and gingivitis over 12 weeks, the differences in favor of the CrossAction being statistically significant. All the toothbrushes tested in this investigation were found to be safe with no evidence of hard or soft tissue trauma.

Purpose: To compare the plaque removal efficacy and safety of a new advanced manual toothbrush, the Oral-B CrossAction, with seven other toothbrushes., Materials and Methods: Seven independent, cross-over design clinical studies were conducted using the same examiner who was blind to the identity of the test products and treatment assignments. In each study, approximately 75 healthy adult subjects from a general population brushed with their randomly assigned toothbrush (CrossAction or comparison brush) at Visit 1 for 1 min without supervision or instruction in brushing technique. Subjects returned after a 1-week washout period and brushed with the alternate toothbrush (Visit 2). Plaque was evaluated before and after brushing using the Rustogi Modified Navy Plaque Index. Statistical analyses were conducted by an independent statistician who remained blind to the identity of all test products., Results: Each of the toothbrushes tested provided significant (P < or = 0.0001) reductions in plaque scores after a single brushing. In each of the studies, the CrossAction toothbrush removed significantly (P < or = 0.0001) greater amounts of whole mouth, gingival margin, and approximal plaque than the compared toothbrush. All toothbrushes were found to be safe, with no changes in oral tissues or restorations observed over the course of each study. The results from these studies were consistent, demonstrating that the CrossAction toothbrush significantly enhances the ability of subjects to remove more plaque during normal brushing compared to seven other toothbrushes.

Purpose: To compare the extrinsic stain-removing properties and the safety of the Braun Oral-B 3D Plaque Remover and the Sonicare Plus electric toothbrush., Materials and Methods: This randomized, parallel group, investigator-blinded study involved 67 subjects and was conducted over 6 weeks. After recruitment, the subjects received a baseline stain assessment (Lobene stain index) and a soft and hard tissue examination, and were then randomized to use either the Sonicare or the 3D device. All subjects were trained to use both devices, and instructed to brush twice daily with their assigned device for 2 min. The subjects' brushing technique was checked after 2 weeks. After a further 4 weeks, the subjects underwent a final stain assessment and soft and hard tissue examination. A questionnaire was also completed., Results: At 6 weeks, oral hard and soft tissue examinations revealed no abrasion or damage in either group. Both brushes produced significant (P < 0.001) reductions from baseline in total stain score, stain area and intensity, but group comparisons showed that these reductions were significantly (P < 0.001) greater for the 3D device.

Purpose: To compare the safety and plaque removal efficacy, and subject preference of two electric toothbrushes in a single-blind, randomized, split-mouth study., Materials and Methods: The devices studied were the Braun Oral-B 3D Plaque Remover and the sonicare electric toothbrush. The 3D toothbrush combines the clinically proven oscillating/rotating action of the D9 with a sonic frequency pulsating action in the direction of the long axis of the bristles, giving a three-dimensional cleaning action. At an initial visit, the subjects (n = 44) were given a baseline examination of the oral soft tissues and a full mouth prophylaxis and instructed in the use of the two products, which was followed by a 4-week training period. After 2 weeks of using each toothbrush on alternate days, brushing technique was checked. After a further 2 weeks, having abstained from oral hygiene for 48 hours, two contralateral quadrants of the mouth were randomly assigned to be cleaned by the subjects with each toothbrush. Plaque assessments and soft tissue examinations were made before and after brushing. Plaque was evaluated according to a refinement of the Modified Navy Plaque Index. At the end of the study, subjects completed a product evaluation questionnaire., Results: Plaque levels were significantly reduced by both toothbrushes (P = 0.001), but the efficacy of the 3D electric toothbrush was significantly greater than that of the sonicare toothbrush (P = 0.001) for all comparisons. Plaque reduction was particularly marked in the interproximal areas, reaching 87% with the 3D product, compared with 68% for sonicare (P = 0.001). In the responses to the questionnaire, the majority of subjects stated that they preferred the 3D toothbrush (88% vs 12%), mainly because of the smaller size of the brush, ease of control and overall maneuverability.