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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: FCI System

Current Primary Outcome: A point-nasion-B point (ANB) angle change [ Time Frame: 6-12 months ]

ANB change is measured in lateral cephalograms between the beginning (T0) and the end (T1) of the treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overjet change using dental silicone impression [ Time Frame: 6-12 months ]
    Assessment of the overjet change between the beginning (T0) and end (T1) of the treatment using dental silicone impression.
  • Cephalometric analysis (Tweed analysis of lateral cephalograms) [ Time Frame: 6-12 months ]
    Assessment of cephalometric measurement changes between T0 and T1 based on Tweed analysis of lateral cephalograms: the lower and upper incisor inclination (I/APog and i/APog) and mandibular corpus growth increase will be investigated in particular.
  • Nasal ventilation (Peak Nasal Inspiratory Flow (PNIF) change) [ Time Frame: 6-12 months ]
    Assessment of the Peak Nasal Inspiratory Flow (PNIF) change between T0 and T1. The PNIF is measured with a spirometer.
  • Treatment acceptability (subjective) [ Time Frame: 6-12 months ]
    Subjective assessment of the appliance wearing compliance and treatment tolerance/acceptability with auto-questionnaire and filling up of a diary (wearing timesheet).
  • Compliance (appliance wearing based on patient interview with a questionnaire.) [ Time Frame: 6-12 months ]
    Clinical Assessment of appliance wearing based on patient interview with a questionnaire.


Original Secondary Outcome: Same as current

Information By: FCI System

Dates:
Date Received: April 21, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: September 12, 2016
Last Verified: September 2016