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Clinical Trials in France / NCT05851963
Recruiting Not applicable

Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

NCT05851963 · tracked via the Priya Life Science France tracker
Sponsor
Claude Bernard University
Phase
Not applicable
Started
2025-04-01
Last updated
2026-03-18

Condition(s) studied

Dental Malposition

Investigational drug(s) / intervention(s)

Sonicare Diamond Clean 9000HydroSonic ProOral-B 123Curaprox CS 5460

Sonicare Diamond Clean 9000: Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment

HydroSonic Pro: Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Oral-B 123: Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Curaprox CS 5460: Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Study 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.

Eligibility

Sex
ALL
Min age
11 Years
Max age
15 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Centre de soin dentaire Nancy France Recruiting

More Claude Bernard University trials in France

Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management. Recruiting
Pregnancy Women and Individual Oral Prophylaxis in the Control of Gingival Inflammation (PRE-IOP) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05851963 on ClinicalTrials.gov ↗ ← All trials in France