Actively Recruiting

Phase Not Applicable
Age: 11Years - 15Years
All Genders
Healthy Volunteers
NCT05851963

Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Led by Claude Bernard University · Updated on 2026-03-18

120

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

C

Claude Bernard University

Lead Sponsor

U

University of Nancy

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Who Can Participate

Age: 11Years - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children to be treated with fixed upper and lower braces
  • Aged 11 to 15 years at the start of treatment
  • One parent or legal guardian agrees to the study terms and signs the consent form
  • The adolescent agrees to the study terms and signs the consent form
Not Eligible

You will not qualify if you...

  • Fewer than 20 permanent teeth with braces or brackets
  • Presence of untreated cavities
  • Bleeding on probing greater than 10%
  • Gingival pocket larger than 5 mm
  • Presence of fixed prosthetic restorations
  • Any enamel development defects
  • Dental anomalies or labial restorations on teeth
  • Need for orthognathic surgeries
  • Presence of systemic diseases such as diabetes, hepatic, renal, hematologic, or cardiovascular conditions
  • Use of medications affecting gingival health (e.g., calcium channel blockers, ciclosporin, anticoagulants)
  • Long-term use of antibiotics or anti-inflammatory drugs
  • Smoking habit
  • Physical or mental problems affecting manual dexterity
  • Inability to answer questions or uncooperative behavior

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre de soin dentaire

Nancy, France

Actively Recruiting

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Research Team

F

Florence Carrouel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances | DecenTrialz