Dentofacial Functional Disorder
Conditions
Brief 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. 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.
Interventions
DEVICETwiCare®.
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No appearance of more than one injury that can not be attributed to causes other than the orthosis | 11 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview) | 11 weeks |
| The subjective assessment of the compliance of wearing the brace by patient by self questionnaire | 11 weeks |
| The subjective assessment of patient acceptability questionnaires self treatment | 11 weeks |
| The support type envisaged endline by the doctor | 11 weeks |
Countries
France
Outcome results
None listed