TerminatedNot Applicable

Early Treatment for Class II Division 1 Malocclusion With Twicare® and Herbst Removable Appliances

Stopped: the study is discarded by the sponsor.

France62 participantsStarted 2015-07

Plain-language summary

The aim of this prospective, multicentric, randomized, open-label study is to assess the efficacy of the removable Twicare® as mandibular propulsive appliance in children aged from 7 to 12 years old in the course of their orthodontic treatment, showing its noninferiority with the removable Herbst. One untreated group will be included to control the internal validity of the study as recommend in noninferiority trials. Patients will have a follow-up every two months during 6 to 12 months as planned in routine care.

Who can participate

Age range

7 Years – 12 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 with Class II division 1 malocclusion * Overjet ≥ 4 mm, * ANB \> 4°, * Good cooperation (motivation and good dental hygiene), * Incisors width compatible with the available Twicare® appliance sizes, according to the manufacturer recommendations. * Written Informed Consent of the Child, * Affiliated to health insurance, * Parents able to receive informed consent and to express their approval for their child to take part in this investigation. Exclusion Criteria: * Non well-balanced periodontal disease, * Temporal-mandibular dysfunction, * Severe bruxism noctural episodes, * Known allergy or intolerance to one of the activators' components. * Foreseeable follow-up difficulties, * Minor under guardianship, * Simultaneous participation to an interventional study.

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

A point-nasion-B point (ANB) angle change

Timeframe: 6-12 months

Trial details

NCT IDNCT02428621

SponsorFCI System

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Malocclusion, Angle Class II, Division 1 trials