Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances (NCT05851963) | Clinical Trial Compass
RecruitingNot Applicable
Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances
France120 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range
11 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of gingival bleeding from baseline during orthodontic treatment
Timeframe: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)