Randomized multicenter study on the plaque removal efficacy of 2 interdental brushes around the base of orthodontic brackets.

Introduction: The objective of this multicenter study was to analyze the efficacy of cleaning 2 interdental brushes (IDBs) around brackets in patients with fixed orthodontic appliances.

Methods: The study design was a multicenter, randomized, examiner-blinded crossover study with 3 interventions, the first of which was a baseline intervention. This study included 20 patients (12 females, 8 males) aged 12-18 years with fixed orthodontic devices examined at the Department of Orthodontics, University Medical Center of the Johannes Gutenberg University Mainz, and the Children's Dental Clinic St. Gallen. The outcome was a conventional, cylindrically shaped IDB (IDBG-S [IB]; Top Caredent GmbH, Schönau, Germany) was examined in comparison with an innovative waist-shaped IDB (Circum, CDB-8 [CB]; Top Caredent GmbH). The participants did not use the IDB themselves. The brushing procedure was performed professionally by 1 operator (C.E.). Each buccal tooth surface with a bracket was split into 8 areas, the main areas being 1 and 8. These main areas, which were difficult for toothbrushes to reach, were mesial (area 1) and distal (area 8) of the bracket edges in the gingival direction. Plaque index (PI) scores were assessed at 2 examinations before and after the cleaning procedure on 8 tooth surfaces in the area with orthodontic brackets. A computer-generated program randomly allocated the IDB sequence to the participants. Examiners (L.Z.-G. and Y.W.) assessing the outcomes were blinded to the intervention and the randomized allocation of participants to the different IDBs.

Results: Both IDBs showed a plaque removal effect (CB, 0.68 [interquartile range, 0.63-0.77]; IB, 0.43 [interquartile range, 0.33-0.55]). The difference between the 2 IDB was statistically significant (P = 0.002). In particular, the CB yielded a higher plaque removal efficacy (CB effect, 0.68; IB effect, 0.21) at the main areas 1 and 8, which were difficult to reach. Ten participants were randomized to each sequence, and all 20 completed the study. No side effects or adverse events were reported or observed.

Conclusion: The waist-shaped brush head of the CB significantly enhanced plaque reduction in total and particularly in problem areas.

Registration: This trial was registered at the German Clinical Trials Registry (no. DRKS00014088; https://www.drks.de/drks_web/navigate.xxdo?navigationId=trial.HTML&TRIAL_ID=DRKS00014088) PROTOCOL: The protocol was not published before trial commencement.

Funding: This study was supported by the manufacturer Top Caredent GmbH, Schönau, Germany, which provided all interdental brushes used in this study.