Early Treatment for Class II Division 1 Malocclusion With Twicare® and Herbst Removable Appliances (EffTwicare)
Malocclusion, Angle Class II, Division 1
About this trial
This is an interventional treatment trial for Malocclusion, Angle Class II, Division 1 focused on measuring early orthodontic treatment, activator, removable appliance, Twicare®, Herbst appliance
Eligibility Criteria
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.
Sites / Locations
- Orthodontic Private Center
- Department of Orthodontics, Faculty of Dentistry
- Department of Orthodontics, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Twicare® appliance
Removable Herbst appliance
Untreated
Group treated with the Twicare® appliance. This appliance is a removable mandibular propulsive adjustable preformed medical device. It is made out of soft and stiff thermoplastics. Its two gutters are linked to each other according to different antero-posterior positions. It is EC marked since 2011.
Group treated with the removable Herbst appliance. This appliance is a medical device measured made composed of telescopic metallic hinges and resin gutters made-to-measure based on dental impression.
Children will not wear any interceptive activator. They will have a routine follow-up with their orthodontist waiting for the placing of a fixed appliance.