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

February 8, 2018 updated by: FCI System

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cherbourg, France
        • Orthodontic Private Center
      • Nantes, France
        • Department of Orthodontics, Faculty of Dentistry
      • Rennes, France
        • Department of Orthodontics, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Twicare® appliance
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.
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).
Active Comparator: Removable Herbst appliance
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.
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).
No Intervention: Untreated
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-12 months
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.
6-12 months
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.
6-12 months
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).
6-12 months
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.
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FCI System

Investigators

  • Principal Investigator: Stéphane Renaudin, Dr, Department of Othodontics, Faculty of Dentistry, University of Nantes, Nantes, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01629-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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