Study Stopped
the study is discarded by the sponsor.
Early Treatment for Class II Division 1 Malocclusion With Twicare® and Herbst Removable Appliances
EffTwicare
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
1 other identifier
interventional
62
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFebruary 9, 2018
February 1, 2018
2.3 years
April 21, 2015
February 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6-12 months
Secondary Outcomes (5)
Overjet change using dental silicone impression
6-12 months
Cephalometric analysis (Tweed analysis of lateral cephalograms)
6-12 months
Nasal ventilation (Peak Nasal Inspiratory Flow (PNIF) change)
6-12 months
Treatment acceptability (subjective)
6-12 months
Compliance (appliance wearing based on patient interview with a questionnaire.)
6-12 months
Study Arms (3)
Twicare® appliance
EXPERIMENTALGroup 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.
Removable Herbst appliance
ACTIVE COMPARATORGroup 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.
Untreated
NO INTERVENTIONChildren will not wear any interceptive activator. They will have a routine follow-up with their orthodontist waiting for the placing of a fixed appliance.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FCI Systemlead
Study Sites (3)
Orthodontic Private Center
Cherbourg, France
Department of Orthodontics, Faculty of Dentistry
Nantes, France
Department of Orthodontics, Faculty of Dentistry
Rennes, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane Renaudin, Dr
Department of Othodontics, Faculty of Dentistry, University of Nantes, Nantes, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2015
First Posted
April 29, 2015
Study Start
July 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
February 9, 2018
Record last verified: 2018-02