A randomized, 3-month, parallel-group clinical trial to compare the efficacy of electric 3-dimensional toothbrushes vs manual toothbrushes in maintaining oral health in patients with fixed orthodontic appliances. 2021

Ioulia-Maria Mylonopoulou, and Eudoxie Pepelassi, and Phoebus Madianos, and Demetrios J Halazonetis
Department of Orthodontics, School of Dentistry, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: marilimyl@yahoo.com.

BACKGROUND The aim of this single-blinded, parallel-group, randomized clinical trial was to compare the efficacy of electric 3-dimensional (3D) toothbrushes and manual toothbrushes in removing plaque and reducing gingival inflammation in orthodontic patients. METHODS Eighty adolescents with fixed orthodontic appliances in both arches were randomized at a 1:1 ratio, with an equal number of both sexes, in this examiner blinded, parallel clinical trial. Eligibility criteria included subjects aged between 12 and 16 years, good general health, nonextraction orthodontic treatment, and plaque-induced gingivitis, excluding patients with active caries or periodontitis, tooth agenesis, syndromes, disabilities, and craniofacial deformities, ≥2 cervical and/or proximal fillings, dental prostheses or dental implants, and subjects smoking or using antibiotics or medication predisposing to gingival enlargement. Patients were assigned to use either an electric 3D orthodontic toothbrush (Oral-B Pro-1000 with Oral-B Ortho head; Procter & Gamble, Cincinnati, Ohio) or a manual toothbrush (Oral-B Orthodontic brush; Procter & Gamble) and instructed to brush twice daily for 2 minutes. The main outcomes were: (1) plaque removal, assessed with the Modified Silness and Löe plaque index and the Modified Full Mouth Plaque Score, and (2) gingival inflammation reduction, assessed with the Modified Silness and Löe Gingival Index and the Modified Simplified Gingival Index. Measurements were taken at baseline, 1, 2, and 3 months. Randomization was achieved with 2 random sequences, one for each brush, written and sealed in opaque numbered envelopes. Blinding was possible for outcome assessment only. RESULTS Considerable variability was observed among patients in the values of all dependent variables. There was no difference between interventions over time for any of the outcomes, and the main effects for treatment and time were also not statistically significant. For Modified Silness and Löe plaque index, the interaction was 0.001 (95% confidence interval, -0.011 to 0.013; P = 0.89). CONCLUSIONS No difference in plaque removal efficacy and gingival inflammation reduction was found between the electric 3D and manual toothbrushes in adolescents with fixed orthodontic appliances. Therefore, orthodontists should focus on enhancing their patients' dental awareness and oral hygiene, along with professional prophylaxis and other oral hygiene aids, independently of the brush used. BACKGROUND This trial was registered at ClinicalTrials.gov (Identifier: NCT02699931). METHODS The protocol was not published before trial commencement. BACKGROUND Electric and manual toothbrushes and toothpastes for all participants were provided by Procter & Gamble (Oral-B). Miscellaneous costs were covered by the participating departments.

UI MeSH Term Description Entries
D008297 Male Males
D009909 Oral Health The optimal state of the mouth and normal functioning of the organs of the mouth without evidence of disease. Health, Oral
D009967 Orthodontic Appliances Devices used for influencing tooth position. Orthodontic appliances may be classified as fixed or removable, active or retaining, and intraoral or extraoral. (Boucher's Clinical Dental Terminology, 4th ed, p19) Appliance, Orthodontic,Appliances, Orthodontic,Orthodontic Appliance
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D003774 Dental Plaque Index An index which scores the degree of dental plaque accumulation. Dental Plaque Indexes,Dental Plaque Indices,Index, Dental Plaque,Indexes, Dental Plaque,Indices, Dental Plaque
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D005260 Female Females
D005891 Gingivitis Inflammation of gum tissue (GINGIVA) without loss of connective tissue. Gingivitides
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077744 Orthodontic Appliances, Fixed ORTHODONTIC APPLIANCES attached to the teeth by adhesive material which cannot be removed from the mouth by the patient. These devices apply force to the teeth and supporting structures, thereby producing changes which control their growth and development. Bonded Retainer,Fixed Appliances,Fixed Functional Appliances,Fixed Retainer,Permanent Retainer,Appliance, Fixed,Appliance, Fixed Functional,Appliance, Fixed Orthodontic,Appliances, Fixed,Appliances, Fixed Functional,Appliances, Fixed Orthodontic,Bonded Retainers,Fixed Appliance,Fixed Functional Appliance,Fixed Orthodontic Appliance,Fixed Orthodontic Appliances,Fixed Retainers,Functional Appliance, Fixed,Functional Appliances, Fixed,Orthodontic Appliance, Fixed,Permanent Retainers,Retainer, Bonded,Retainer, Fixed,Retainer, Permanent,Retainers, Bonded,Retainers, Fixed,Retainers, Permanent

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