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 range7 Years – 12 Years

SexALL

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.

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