Malocclusion, Angle Class II, Division 1EffTwicareNCT02428621
Early Treatment for Class II Division 1 Malocclusion With Twicare® and Herbst Removable Appliances
A study testing Twicare® appliance and Removable Herbst appliance in people with Malocclusion, Angle Class II, Division 1, run by FCI System at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Malocclusion, Angle Class II, Division 1
- What is being tested?
- Twicare® appliance and Removable Herbst appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Orthodontic Private Center
Cherbourg
Department of Orthodontics, Faculty of Dentistry
Nantes
Department of Orthodontics, Faculty of Dentistry
Rennes
About this study
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
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.
Read the 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
- Being tested
- Twicare® appliance, Removable Herbst appliance
- Keywords
- early orthodontic treatment, activator, removable appliance, Twicare®, Herbst appliance
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twicare® applianceDevice
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).
Removable Herbst applianceDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Twicare® appliance | Experimental | 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. Receives: Device: Twicare® appliance |
| Removable Herbst appliance | Active comparator | 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. Receives: Device: Removable Herbst appliance |
| Untreated | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-12 months
Secondary outcomes (5)
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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.
Measured: 6-12 months
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).
Measured: 6-12 months
Compliance (appliance wearing based on patient interview with a questionnaire.)
Clinical Assessment of appliance wearing based on patient interview with a questionnaire.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: the study is discarded by the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class II, Division 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- FCI System
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stéphane Renaudin, Dr, Principal investigator, Department of Othodontics, Faculty of Dentistry, University of Nantes, Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428621
- Sponsor's protocol ID
- 2014-A01629-38
- Acronym
- EffTwicare
- Status last verified
- Feb 2018
- First submitted
- 21 Apr 2015
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02428621
- Acronym / sponsor ID
- EffTwicare / 2014-A01629-38
- Conditions
- Malocclusion, Angle Class II, Division 1
- Keywords
- early orthodontic treatment, activator, removable appliance, Twicare®, Herbst appliance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study is discarded by the sponsor.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- FCI SystemIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Twicare® appliance | Experimental | Device: Twicare® applianceGroup 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 comparator | Device: Removable Herbst applianceGroup 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 intervention | –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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twicare® applianceEarly 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 | Twicare® appliance |
| Removable Herbst applianceEarly 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). | Device | Removable Herbst appliance |
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.
5 secondary outcomes
Overjet change using dental silicone impression
Time frame: 6-12 months
Cephalometric analysis (Tweed analysis of lateral cephalograms)
Time frame: 6-12 months
Nasal ventilation (Peak Nasal Inspiratory Flow (PNIF) change)
Time frame: 6-12 months
Treatment acceptability (subjective)
Time frame: 6-12 months
Compliance (appliance wearing based on patient interview with a questionnaire.)
Time frame: 6-12 months
Results and safety
The study was stopped early (reason given: the study is discarded by the sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Twicare® applianceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Renaudin, Dr principal investigator
Department of Othodontics, Faculty of Dentistry, University of Nantes, Nantes, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twicare® appliance and Removable Herbst appliance in people with Malocclusion, Angle Class II, Division 1, run by FCI System at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the study is discarded by the sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A point-nasion-B point (ANB) angle change (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.