Toothbrushes in Daily Practice in Patients with Fixed Orthodontic Appliances

Not Applicable

Recruiting

• Conditions: Dental Malposition
• Interventions: Device: HydroSonic Pro; Device: Sonicare Diamond Clean 9000; Device: Oral-B 123; Device: Curaprox CS 5460

• Registration Number: NCT05851963
• Lead Sponsor: Claude Bernard University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-10
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Start: 2025-04-01
• Primary Completion: 2025-07-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group using hydrosonic toothbrush	HydroSonic Pro	Patients will be asked to use a hydrosonic toothbrush for 24 months
Group using sonic toothbrush	Sonicare Diamond Clean 9000	Patients will be asked to use a sonic toothbrush for 24 months
Group using manual toothbrush	Oral-B 123	Patients will be asked to use a manual toothbrush for 24 months
Group using manual toothbrush with 5460 strands	Curaprox CS 5460	Patients will be asked to use a manual toothbrush with 5460 strands for 24 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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
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
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
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
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

Trial Locations

Locations (1)

Centre de soin dentaire; 🇫🇷 Nancy, France