Background: Fixed orthodontic appliances hamper oral hygiene procedures. The consequences are gingivitis and white spot lesions. Fifty to 70% of patients treated with braces encounter these problems. Their care in the USA represents an annual cost of five hundred million dollars. Initial education and motivation for oral hygiene depend on two categories of factors: firstly, practical prophylactic measures (instruments and medication, professional care) and secondly, the educational component: choice of communication technique, frequency, and nature of hygiene instructions. This trial aims to study this last component. Its main objective is to compare three methods' effectiveness of oral hygiene education in adolescent patients treated with braces in terms of biofilm (plaque) control. The secondary objectives are the evaluation of these methods' effectiveness regarding gingival inflammation and the maintenance of hygiene during the first 6 months of treatment.
Methods: This study is a prospective randomized controlled trial of superiority. It evaluates the effectiveness of three hygiene education techniques. A total of 90 patients from the University Hospital Center of Rennes will be randomized into 3 parallel groups with a 1:1:1 ratio. Each will benefit from a different educational method: oral and/or practical. The main outcome will be the average plaque index for each group after 6 months of treatment. Additional outcomes will be the average gingival index for each group and the plaque and gingival indices over 6 months.
Discussion: The effectiveness of preventive procedures for optimizing oral hygiene during orthodontics is based on ambiguous literature. As a result, it is difficult to draw conclusions and to translate them into everyday practice. Sixty-eight percent of the orthodontists support the development of guidelines for education. The aim of this study is to standardize methods of oral hygiene education during orthodontic fixed treatment. The purpose of this study would be to provide practitioners with a concrete education program through guidelines dedicated to the method having the best results.
Trial registration: ClinicalTrials.gov NCT04444154 . Registered on 22 June 2020. SI CNRIPH ID 8011N° 20.04.27.58337. Registered on 29 July 2020.
Keywords: Auditory learning; Education; Guideline; Kinesthetic learning; Oral health; Orthodontic treatment; Prevention; Study protocol; Visual learning.