Dental Malposition
Conditions
Keywords
toothbrush, oral prophylaxis, adolescents, orthodontic appliances
Brief summary
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.
Interventions
DEVICESonicare Diamond Clean 9000
Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment
DEVICEHydroSonic Pro
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
DEVICEOral-B 123
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
DEVICECuraprox CS 5460
Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
Sponsors
Claude Bernard University
University of Nancy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel Assignment This trial is designed as an four-arm parallel cluster randomized controlled trial and an allocation ratio of 1:1:1:1
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * Presence of fixed prosthetic restorations * Presence of any enamel development defect * Presence of dental anomalies or direct/indirect labial restorations on teeth * Patients requiring orthognathic surgeries * Presence of systemic diseases (diabetes, hepatic, renal, hematologic, cardiovascular) * Use of medications that may affect gingival health (such as calcium channel blockers, ciclosporin and anticoagulants) * Use of antibiotics and anti-inflammatory drugs for any purpose over a long period of time. * Having a smoking habit * Having a physical or mental problem that affects manual dexterity * Being unable to answer questions or being uncooperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of gingival bleeding from baseline during orthodontic treatment | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | Change of gingival inflammation in patients with fixed orthodontic appliances using manual or electric toothbrushes in daily practice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | Questionnaire to assess the acceptability of oral hygiene products by patients |
| Effect on gingival inflammation | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | gingival index |
| Effect on gingival bleeding | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | Bleeding on Probing |
| Effect on dental plaque | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | plaque index |
| Effect on gingival tissue | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | micro-osteoperforation |
| Effect on gingival attachment | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | clinical attachment loss |
| Enamel lesions | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | Assess the incidence of initial enamel lesions |
| Dentinal hypersensitivity | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | Assess the incidence of dentinal hypersensitivity |
| Salivary acidity | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | Measure of pH |
Countries
France
Contacts
CONTACTFlorence Carrouel, PhD
Outcome results
None listed