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

Primary Purpose

Malocclusion, Angle Class II, Division 1

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Twicare® appliance
Removable Herbst appliance
Sponsored by
FCI System
About
Eligibility
Locations
Arms
Outcomes
Full info

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

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Twicare® appliance

Removable Herbst appliance

Untreated

Arm Description

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.

Outcomes

Primary Outcome Measures

A point-nasion-B point (ANB) angle change
ANB change is measured in lateral cephalograms between the beginning (T0) and the end (T1) of the treatment.

Secondary Outcome Measures

Overjet change using dental silicone impression
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)
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)
Assessment of the Peak Nasal Inspiratory Flow (PNIF) change between T0 and T1. The PNIF is measured with a spirometer.
Treatment acceptability (subjective)
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.)
Clinical Assessment of appliance wearing based on patient interview with a questionnaire.

Full Information

First Posted
April 21, 2015
Last Updated
February 8, 2018
Sponsor
FCI System
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1. Study Identification

Unique Protocol Identification Number
NCT02428621
Brief Title
Early Treatment for Class II Division 1 Malocclusion With Twicare® and Herbst Removable Appliances
Acronym
EffTwicare
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 Malocclusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
the study is discarded by the sponsor.
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FCI System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II, Division 1
Keywords
early orthodontic treatment, activator, removable appliance, Twicare®, Herbst appliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twicare® appliance
Arm Type
Experimental
Arm Description
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.
Arm Title
Removable Herbst appliance
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Untreated
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Twicare® appliance
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Removable Herbst appliance
Intervention Description
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).
Primary Outcome Measure Information:
Title
A point-nasion-B point (ANB) angle change
Description
ANB change is measured in lateral cephalograms between the beginning (T0) and the end (T1) of the treatment.
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Overjet change using dental silicone impression
Description
Assessment of the overjet change between the beginning (T0) and end (T1) of the treatment using dental silicone impression.
Time Frame
6-12 months
Title
Cephalometric analysis (Tweed analysis of lateral cephalograms)
Description
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.
Time Frame
6-12 months
Title
Nasal ventilation (Peak Nasal Inspiratory Flow (PNIF) change)
Description
Assessment of the Peak Nasal Inspiratory Flow (PNIF) change between T0 and T1. The PNIF is measured with a spirometer.
Time Frame
6-12 months
Title
Treatment acceptability (subjective)
Description
Subjective assessment of the appliance wearing compliance and treatment tolerance/acceptability with auto-questionnaire and filling up of a diary (wearing timesheet).
Time Frame
6-12 months
Title
Compliance (appliance wearing based on patient interview with a questionnaire.)
Description
Clinical Assessment of appliance wearing based on patient interview with a questionnaire.
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Renaudin, Dr
Organizational Affiliation
Department of Othodontics, Faculty of Dentistry, University of Nantes, Nantes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthodontic Private Center
City
Cherbourg
Country
France
Facility Name
Department of Orthodontics, Faculty of Dentistry
City
Nantes
Country
France
Facility Name
Department of Orthodontics, Faculty of Dentistry
City
Rennes
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.medventiv.com/index_en.php
Description
Twicare® appliance

Learn more about this trial

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

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