Dentofacial Functional DisorderTolTwiCareNCT02907450
TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis
A study testing TwiCare®. in people with Dentofacial Functional Disorder, run by Nantes University Hospital at 1 site in France.
Trial summary
The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention. The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Dentofacial Functional Disorder
- What is being tested?
- TwiCare®.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Mar 2015
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- male or female patients, where the laying of a brace phase of interception or contention after dental-facial orthodontic treatment is indicated (an intended age range of 8-18 years, not exhaustive or limiting) , recipient of a social security scheme, for which a management of the orthosis is acquired.
- incisor width compatible with the sizes of TwiCare® orthotics available, according to manufacturer's recommendations
- patient in good general health
- parent or guardian able to receive clear information, and express their opposition not to the patient's participation in this research
- for patients with malocclusions, the incisors (maxillary and mandibular) should be aligned.
Who cannot join
- General chronic health problem, unbalanced
- obvious oral ventilation
- history of temporomandibular dysfunction
- nocturnal episodes of severe bruxism
- unbalanced periodontal disease
- allergies or intolerances known to one of the constituents of the orthosis
Show all 12Show fewer
- opposition of representatives of the parental authority (parent or guardian) or the patient himself at the patient's participation in this research
- patient unable to respond to the questionnaire
- monitoring difficulties (going on holiday, imminent change, remoteness, lack of motivation)
- simultaneous participation in intervention research
- pregnant Patient on examination of the latter, according to his age
- Incisive (maxilla and / or mandible) unaligned
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale
Nantes, 44093
About this study
The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention.
The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study.
The comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.
- Conditions
- Dentofacial Functional Disorder
- Being tested
- TwiCare®.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TwiCare®.Device
| Study group | Role | What they receive |
|---|---|---|
| Clinical evaluation of the tolerance of the orthosis | Experimental | Not described Receives: Device: TwiCare®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
No appearance of more than one injury that can not be attributed to causes other than the orthosis
Measured: 11 weeks
Secondary outcomes (4)
The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview)
Measured: 11 weeks
The subjective assessment of the compliance of wearing the brace by patient by self questionnaire
Measured: 11 weeks
The subjective assessment of patient acceptability questionnaires self treatment
Measured: 11 weeks
The support type envisaged endline by the doctor
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial Functional DisorderStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907450
- Sponsor's protocol ID
- BRD/11/2-W
- Other IDs
- 2011-A01106-35
- Acronym
- TolTwiCare
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis
- ClinicalTrials.gov ID
- NCT02907450
- Acronym / sponsor ID
- TolTwiCare / BRD/11/2-W
- Conditions
- Dentofacial Functional Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Sep 2016 (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 TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention.
The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study.
The comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical evaluation of the tolerance of the orthosis | Experimental | Device: TwiCare®. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- male or female patients, where the laying of a brace phase of interception or contention after dental-facial orthodontic treatment is indicated (an intended age range of 8-18 years, not exhaustive or limiting) , recipient of a social security scheme, for which a management of the orthosis is acquired.
- incisor width compatible with the sizes of TwiCare® orthotics available, according to manufacturer's recommendations
- patient in good general health
- parent or guardian able to receive clear information, and express their opposition not to the patient's participation in this research
- for patients with malocclusions, the incisors (maxillary and mandibular) should be aligned.
Key exclusion criteria (12 listed)
- General chronic health problem, unbalanced
- obvious oral ventilation
- history of temporomandibular dysfunction
- nocturnal episodes of severe bruxism
- unbalanced periodontal disease
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®. | Device | Clinical evaluation of the tolerance of the orthosis |
Primary outcome
No appearance of more than one injury that can not be attributed to causes other than the orthosis
Time frame: 11 weeks
4 secondary outcomes
The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview)
Time frame: 11 weeks
The subjective assessment of the compliance of wearing the brace by patient by self questionnaire
Time frame: 11 weeks
The subjective assessment of patient acceptability questionnaires self treatment
Time frame: 11 weeks
The support type envisaged endline by the doctor
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Dentofacial Functional Disorder
Active, not recruitingObservational study
Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques
Class II Malocclusion, Dentofacial Deformities
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TwiCare®. in people with Dentofacial Functional Disorder, run by Nantes University Hospital at 1 site 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
No appearance of more than one injury that can not be attributed to causes other than the orthosis (time frame: 11 weeks). 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 20 Sep 2016.