Blinded Clinical Evaluation of a New Toothbrush Design.

OBJECTIVE:The purpose of this single-blind, crossover study was to compare plaque removal associated with a new manual toothbrush, the O'Nano and a best-selling, commercially available manual toothbrush, the Oral-B Indicator 40. The O'Nano toothbrush has a patented "one-piece molded design" made of Thermal Plastic Urethane, a plastic that has been used in medical devices. METHODOLOGY:Over a six-week period, 40 subjects participated. Following random assignment, 22 subjects started with the O'Nano brush and the remaining started with the Oral-B Indicator 40 brush. Crossover occurred after two-weeks' use of each brush (two-week washout in between). Plaque was scored before and after brushing using the Turesky modification of the Quigley-Hein Index (T/Q-H). Plaque accumulation was 12 to 18 hours prior to examination and brushing. RESULTS:Thirty-nine subjects completed the study; one subject was dropped for non-compliance. Groups were virtually identical at the onset in plaque level scores by study design. In comparison to baseline, both brushes achieved significant (p < 0.001) plaque reductions (gains) with a matched-paired comparison t-test. The O'Nano brush gain was 0.445 (18%) per subject and the Oral-B Indicator 40 brush was 0.504 (20%) per subject. The difference in plaque removal capability between brushes averaged 0.60 in favor of the Oral-B Indicator 40 brush, a non-significant (p = 0.20) finding determined by a matched-paired comparison t-test, which is identical to the repeated measures ANOVA when there are two groups and two time periods. Standard deviation (SD) was smaller for the O'Nano brush in plaque reduction scores (0.183 < 0.235). This difference was tested and found to be non-significant with this particular group size. CONCLUSION:Statistical analysis of T/Q-H scores demonstrated that the O'Nano brush is comparable to the Oral-B Indicator 40 brush under the conditions of this study protocol. With this small study group the slight differences in plaque removal efficiency between both brushes was not significant. The unique "one-piece molded" design of the O'Nano brush was not evaluated for durability in comparison to a more conventional brush, the Oral-B 40.