Dentofacial Functional Disorder Clinical Trial
— TolTwiCare
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 8 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | No appearance of more than one injury that can not be attributed to causes other than the orthosis | 11 weeks | Yes | |
| Secondary | The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview) | 11 weeks | No | |
| Secondary | The subjective assessment of the compliance of wearing the brace by patient by self questionnaire | 11 weeks | No | |
| Secondary | The subjective assessment of patient acceptability questionnaires self treatment | 11 weeks | No | |
| Secondary | The support type envisaged endline by the doctor | 11 weeks | No |