Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles and an ADA Reference Toothbrush on Established Gingivitis and Supragingival Plaque over a 12-Week Period.

OBJECTIVES Evaluation of the efficacy of a soft toothbrush with tapered-tip bristles (Test Toothbrush) and an ADA reference soft toothbrush (ADA Toothbrush) on established gingivitis and supragingival plaque over a 12-week period. METHODS This randomized, single-center, examiner-blind, two-cell, parallel clinical research study assessed plaque removal by the comparison of pre- to- post-brushing after a single use, and again after six- and 12-weeks' use, using the Quigley-Hein Plaque Index, Turesky Modification. The study also assessed gingivitis after six weeks and 12 weeks using the Löe & Silness Gingival Index. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Subjects had the study procedure explained to them both orally and by written instructions. Subjects then gave written consent to participate before entry into the study. Following an examination for plaque (pre-brushing) and gingivitis (baseline), the subjects were randomized into two balanced groups, each group assigned to one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS Seventy-one (71) subjects complied with the protocol and completed the clinical study. Compared to the ADA Toothbrush, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 71.1% in whole mouth plaque index scores, 43.8% in plaque severity index scores, and 81.3% in interproximal sites plaque scores after a single tooth brushing. After six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 700% in whole mouth gingival index scores, 700% in gingivitis severity index scores, and 400% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 188.9% in whole mouth plaque index scores, 165% in plaque severity index scores, and 203% in interproximal sites plaque scores compared to the ADA Toothbrush. After 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 266.7% in whole mouth gingival index scores, 300% in gingivitis severity index scores, and 250% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 158.1% in whole mouth plaque index scores, 143.5% in plaque severity index scores, and 145.4% in interproximal sites plaque scores compared to the ADA Toothbrush. CONCLUSIONS This study demonstrated that a soft toothbrush with tapered-tip bristles provided a significantly greater reduction in supragingival plaque after a single tooth brushing, as well as after six and 12 weeks of twice-daily use, compared to the ADA Toothbrush. After six and 12 weeks of twice-daily use, it also provided a significantly greater reduction in gingivitis as compared to the ADA Toothbrush.