A clinical trial of the meridol toothbrush with conical filaments: evaluation of clinical effectiveness and subjective satisfaction.
OBJECTIVE
The present study was designed to evaluate the health promotion effectiveness, especially at the gingival margin, and the subjective satisfaction of a new toothbrush with soft conical filaments.


METHODS
Sixty-eight healthy adult subjects participated in the clinical trial and were randomly divided into a test group (meridol toothbrush) or control group (standard ADA reference toothbrush). Subjects were given oral hygiene instructions and a pre-study cleaning by a dental hygienist. Clinical examinations included the Gingival Index (GI), Bleeding Index (BLI), and Patient Hygiene Performance Index (PHP) for plaque levels (before and after brushing), and were conducted at baseline, 30, and 60 days. A self-administered satisfaction questionnaire was applied at 30 and 60 days. The statistical test employed for change within each test group was repeated measures ANOVA, and ANCOVA was employed for between-group analysis. For measures of satisfaction, Fisher's Exact test was applied when comparing the percentages of answers.


RESULTS
For the GI, the test group demonstrated a highly significant statistical decrease (from GI = 0.22 to GI = 0.13, p = 0.0004). The control group showed less of a decrease with statistical significance (GI = 0.21 to GI = 0.16, p = 0.05). For the BLI, the test group also demonstrated a highly significant statistical decrease (from BLI = 0.29 to BLI = 0.11, p = 0.0013), while the control group showed a very small decrease with no statistical significance (BLI = 0.24 to BLI = 0.17). The analyses of the PHP plaque levels after brushing showed significant and similar decreases for both groups over the study period (test group: p = 0.04, controls: p = 0.01). In an analysis of PHP before brushing, both brushes showed increases from baseline to day 30. This increase continued from day 30 to day 60 for the control group. For the test group, there was a significant decrease from day 30 to day 60 (PHP = 0.84 to PHP = 0.75, p = 0.037). For satisfaction, a significantly higher percentage of test subjects expressed that the brush was "pleasant to use" as compared to controls, both at 30 and 60 days (77% vs. 48%, p = 0.02, 80% vs. 54%, p = 0.04, respectively).


CONCLUSIONS
The initial increase in plaque levels (before brushing) in the test group, is explained as a possible "learning curve" effect of using this new and unconventional brush. It is suggested that the conical filaments clean the subgingival pockets and that this is of important gingival health potential. This subgingival cleansing might not be adequately detected by the PHP index. These results might indicate a gingival health promotion potential for this toothbrush with conical filaments.
Sgan-Cohen
Harold D
HD
Department of Community Dentistry, Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem, Israel. harolds@cc.huji.ac.il
Vered
Yuval
Y
D000328:Adult; D003773:Dental Plaque / Q000628:therapy*; D003774:Dental Plaque Index; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000628:therapy; D005891:Gingivitis / Q000628:therapy; D006801:Humans; D008297:Male; D009910:Oral Hygiene; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D010512:Periodontal Index; D016037:Single-Blind Method; D013499:Surface Properties; D014099:Toothbrushing / Q000295:instrumentation*; D016896:Treatment Outcome