NCT02428621

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

Prospective Multicentric, Open-label, Randomized Study Assessing the Efficacy of the Removable and Adjustable Preformed Twicare® Appliance Versus Removable Herbst Appliance Treatment in Class II Malocclusion

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: FCI System · Industry
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A large number of functional appliances, mandibular advancement activators with various designs, fixed or removable, are used in Class II malocclusion correction; one of the largest means being used is the Herbst. These appliances can be individualized, made to measure by the prosthetist or standardised (on market). A new medical device, EC marked and marketed since 2011, the Twicare®, can be used as positioner, growth activator, but also for lingual re-education. There are numerous publications comparing the activators' effects or the appliance effects on mandibular growth, but none have studied the Twicare®. The aim of this study is to assess the efficacy of this specific removable appliance in mandibular advancement in Class II skeletal in children aged from 7 to 12 years old. The appliance will be compared with the Herbst and 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 until the Class I occlusion is achieved. A lateral cephalogram and a dental silicon impression will be performed at the beginning (T0) and at the end of the treatment (T1) in order to evaluate cephalometric measurement changes, ANB, overjet and canine and molar class evolutions. The data collected at the beginning and at the end of the treatment will be analyzed and compared aware from patient, treatment and time, in order to assess the Twicare® noninferiority compared to the Herbst and to confirm the superiority of these two appliances versus observation. We will study, in parallel, the nasal ventilator function as well as comfort, compliance, tolerance and acceptability of the device via an auto-questionnaire.

Conditions

• Malocclusion, Angle Class II, Division 1

Interventions

Type	Name	Description
DEVICE	Twicare® appliance	Early orthodontic treatment with the Twicare®. The Class II treatment is initiated at the age of 7-12 years and continued as long as the Class I is achieved. The Twicare® is adjusted in mandibular protraction based on the 2/3 of the condylar test and was were worn during 12 to 14 hours a day (at least 4 hours during the day and all night).
DEVICE	Removable Herbst appliance	Early orthodontic treatment with the removable Herbst appliance. The Class II treatment is initiated at the age of 7-12 years and continued as long as the Class I is achieved. The Herbst appliance is adjusted in mandibular protraction based on the 2/3 of the condylar test and was were worn during 12 to 14 hours a day (at least 4 hours during the day and all night).

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2015-04-29
• Last updated: 2018-02-09

Locations

3 sites across 1 country: France