About this trial
Because of the difficulties of disorganizing the dental biofilm in these adolescents with fixed orthodontic treatment, electric toothbrushes have been proposed as an alternative to manual toothbrushes. Electric toothbrushes, available in a wide range of price points, have been developed with the goal of replicating the complex motions required by the manual toothbrush and making plaque removal more efficient. However, the overall effect size is limited, and the clinical relevance is not yet clear. Applied to orthodontics, specialized manual toothbrushes have also recently been developed. Few recent clinical trials have been conducted in patients with orthodontic appliances.
Thus, the question of whether and which type of manual or electric toothbrushes may be beneficial for patients with orthodontic appliances is still unresolved. Given the variety of toothbrushes available on the market, there is a need for sound clinical research to evaluate their effectiveness to guide professional recommendations. This work will provide a significant advance in the knowledge of the potential of the latest generation of electric toothbrushes on gingival inflammation, potentially reducing the risk of caries and gingival lesions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children to be treated with fixed upper and lower braces
11 to 15 years of age at the start of treatment
One parent/legal guardian agrees to the terms and conditions of the study and signs the informed consent form
The adolescent agrees to the terms and conditions of the study and signs the informed consent form
Disqualifiers
Less than 20 permanent teeth with braces or brackets
Presence of untreated cavities
Bleeding greater than 10% on probing
Presence of a gingival pocket larger than 5 mm
Trial design
Parallel
Treatments tested in this trial
Sonicare Diamond Clean 9000
DeviceBrush teeth with the electric toothbrush 1 daily during the orthodontic treatment
HydroSonic Pro
DeviceBrush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Oral-B 123
DeviceBrush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Curaprox CS 5460
DeviceBrush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Treatment groups
Trial outcomes
Primary outcomes
Incidence of gingival bleeding from baseline during orthodontic treatment
Change of gingival inflammation in patients with fixed orthodontic appliances using manual or electric toothbrushes in daily practice
Secondary outcomes
Acceptability
Questionnaire to assess the acceptability of oral hygiene products by patients
Effect on gingival inflammation
gingival index
Effect on gingival bleeding
Bleeding on Probing
Effect on dental plaque
plaque index
Sponsors and contacts
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Claude Bernard University
Lead sponsor
University of Nancy
Collaborator