Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Conditions
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Dental Malposition

Intervention / Treatment
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* Device: Sonicare Diamond Clean 9000
* Device: HydroSonic Pro
* Device: Oral-B 123
* Device: Curaprox CS 5460


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group using sonic toothbrush<br>Patients will be asked to use a sonic toothbrush for 24 months | Device: Sonicare Diamond Clean 9000<br>* Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment<br>|
| Experimental: Group using hydrosonic toothbrush<br>Patients will be asked to use a hydrosonic toothbrush for 24 months | Device: HydroSonic Pro<br>* Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment<br>|
| Placebo Comparator: Group using manual toothbrush<br>Patients will be asked to use a manual toothbrush for 24 months | Device: Oral-B 123<br>* Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment<br>|
| Experimental: Group using manual toothbrush with 5460 strands<br>Patients will be asked to use a manual toothbrush with 5460 strands for 24 months | Device: Curaprox CS 5460<br>* Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Questionnaire to assess the acceptability of oral hygiene products by patients | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 
| Effect on gingival inflammation | gingival index | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 
| Effect on gingival bleeding | Bleeding on Probing | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 
| Effect on dental plaque | plaque index | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 
| Effect on gingival tissue | micro-osteoperforation | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 
| Effect on gingival attachment | clinical attachment loss | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 
| Enamel lesions | Assess the incidence of initial 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) | 
| Dentinal hypersensitivity | Assess the incidence of 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) | 
| Salivary acidity | Measure of pH | T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toothbrush, oral prophylaxis, adolescents, orthodontic appliances