Clinical Evaluation of U-Shaped Sonic Toothbrush on Plaque and Gingivitis

Objectives: This single-center, randomized, controlled, examiner-blind, 30-day parallel trial assessed safety and efficacy of AutoBrush® 360° U-Shaped Toothbrush on plaque and gingivitis, compared to an ADA reference manual toothbrush. The extent of gingival abrasion and recession was evaluated.
Methods: 75 subjects, aged 5-64 years, with mild-to-moderate plaque and gingivitis levels were assigned to brush twice daily with a fluoride toothpaste and: 1)two-minutes with ADA reference manual toothbrush (MTB) or 2) 30-seconds with AutoBrush® (AB). Subjects refrained from oral hygiene for 12-16 hours before exam visits at Baseline, Day 15 and Day 30, received oral examinations, were assessed for Modified Gingival Index (MGI), gingival recession, gingival abrasion, plaque according to Lobene-Soparkar-Modified-Turesky Plaque Index (LSPI). Subjects presented with existing mild-to-moderate gingivitis. Pre-to-Post-brushing plaque assessments were measured Day 30. Treatment means and between-treatment means were assessed by ANCOVA model.
Results: No treatment-related oral adverse events nor group differences were detected for gingival recession and abrasion. Significant gingivitis and plaque reductions were observed for AB compared to MTB at Days 15 and 30 (p<0.0001). AB reduced 32.3% and 44.9% greater whole mouth MGI scores at each visit. In hard-to-reach areas (gumline, proximal and most distal) AB provided greater improvement in gingivitis levels. Whole mouth plaque was reduced 32.3% and 10.9% at Days 15 and 30 compared to the MTB. Improvement in Day 30 Pre-to-Post-brushing plaque scores for AB were significantly better (p<0.001) than MTB for whole mouth, gumline, proximal sites and most distal surfaces at 44.8%, 81.8%, 28.8% and 49.7%, respectively.
Conclusions: Thirty-second brushing with AutoBrush® toothbrush was superior to the MTB in reducing gingivitis and plaque at Days 15 and 30, and demonstrated highly significant plaque removal at Day 30 Pre-to-Post-brush evaluation. Both toothbrushes were well-tolerated and the safety of the AutoBrush® 360 U-Shaped sonic toothbrush was demonstrated in this 30-day study.