Clinical effect of a manual toothbrush with tapered filaments on dental plaque and gingivitis reduction.

PURPOSE

To evaluate the anti-plaque efficacy (Study 1) and the anti-gingivitis efficacy (Study 2) of a manual toothbrush with tapered bristles compared to marketed control manual toothbrushes.

METHODS

Studies 1 and 2 were independent, randomized and controlled, single-center, examiner-blind clinical trials in generally healthy adults. Study 1 included a 2-day acclimation period, followed by a 5-day twice daily toothbrushing test phase with the assigned brush. Baseline and Day 5 pre- and post-brushing plaque levels were assessed via Turesky Modified Quigley-Hein Plaque Index (TMQHPI). In Study 2, subjects with existing gingivitis brushed with their assigned toothbrush twice daily for 4 weeks. Gingivitis was measured using the Mazza Modification of the Papillary Bleeding Index at Baseline and Weeks 2 and 4. In both trials, subjects were randomly assigned to either the manual toothbrush with tapered bristles (Oral-B Super Thin Indicator toothbrush, OM159) or the marketed control (Study 1: Oral-B Complete Clean & Sensitive toothbrush; Study 2: Crest Pro-Health Complete 7 Brush 35 toothbrush) for use with a regular fluoridated dentifrice.

RESULTS

40 (Study 1) and 63 (Study 2) subjects were randomized in each trial. In Study 1, both the tapered bristle and marketed control brushes provided significant (P< 0.0001) mean whole mouth plaque reductions at Day 1 and Day 5 post-brushing relative to pre-brushing as measured via TMQPHI, with no between-brush significant differences. Both groups showed a significant reduction in Day 5 post-brushing mean plaque scores versus Day 1 pre- brushing mean plaque scores (P< 0.0001), but the reductions were not significantly different between groups (P= 0.4274). In Study 2, both the tapered bristle brush and the marketed control brush produced significant (P< 0.0001) reductions in both gingivitis and number of gingival bleeding sites at both Weeks 2 and 4 versus baseline. At Week 4, the tapered filament toothbrush group showed 8.6% less gingivitis (P= 0.0017) and 33.4% fewer bleeding sites (P= 0.0030) versus the control brush. All toothbrushes were well-tolerated.

CLINICAL SIGNIFICANCE

Twice daily customary use of a manual toothbrush with tapered bristles provided clinically meaningful plaque and gingivitis reduction benefits.