- New
- Preprint Article
- 10.21203/rs.3.rs-10989501/v1
The safety-in-use and clinical efficacy of a novel 360° U-shaped sonic toothbrush: a 30-day randomized, controlled study on plaque and gingivitis
- Oct 13, 2026
- Research Square
- Kimberly R Milleman + 6 more +6
Abstract Background: This 30-day single-center, randomized, controlled, examiner-blind, parallel-design clinical trial compared the efficacy in controlling dental plaque and gingivitis of the Autobrush® 360° U-shaped sonic toothbrush to that of an ADA reference soft manual toothbrush. Gingival abrasion and recession were also evaluated to establish safety-in-use. Methods: 77 subjects, aged 5-65 years, with mild-to-moderate plaque and gingivitis levels were assigned to: 1) twice-daily brushing for 2 minutes with the ADA reference manual toothbrush (MTB) and fluoride toothpaste; or 2) twice-daily brushing for 30 seconds with the Autobrush® (AB) and fluoride toothpaste. Subjects refrained from oral hygiene for 12-16 hours prior to each clinical assessment at baseline, Day 15 and Day 30. Evaluations comprised assessments of oral soft and hard tissue, gingivitis, gingival recession, gingival abrasion and supragingival plaque. Pre-to-post-brushing plaque assessments were measured on Day 30. No dental prophylaxis was performed. Within- and between-treatment means were assessed using an ANCOVA model. Results: No treatment-related oral adverse events, nor differences between groups for gingival recession and abrasion were detected. Significant gingivitis and plaque reductions were observed for AB compared to MTB on Days 15 and 30 (p<0.0001). Compared to MTB, AB reduced whole-mouth gingivitis scores by 25% and 41%, respectively. These overall results comprised improvements in gingivitis levels in all the assessed hard-to-reach areas compared to MTB. Whole-mouth plaque scores were reduced 26.5% and 27.7% on Days 15 and 30, respectively, for the AB compared to the MTB. Improvement in Day 30 post-brushing plaque scores for AB were significantly better (p<0.0001) than MTB for whole-mouth, gumline, proximal and most distal surfaces at 43%, 82%, 27% and 69%, respectively. Conclusion: 30-seconds brushing with the Autobrush® toothbrush was superior to 2-minutes brushing with an ADA-accepted reference manual toothbrush in reducing gingivitis and plaque after 15- and 30-days use. It also demonstrated highly significant levels of plaque removal after a single brushing on Day 30. Both toothbrushes were well-tolerated and the safety-in-use of the Autobrush® was demonstrated in this 30-day study. Clinical Trial Registration: This clinical study was registered retrospectively on ClinicalTrials.gov under entry NCT06122376. The first submission date was 05-11-2023.
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