Clinical trial NCT02907450: TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentofacial Functional Disorder
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: No appearance of more than one injury that can not be attributed to causes other than the orthosis
timeFrame: 11 weeks
Secondary outcomes:
measure: The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview)
timeFrame: 11 weeks
measure: The subjective assessment of the compliance of wearing the brace by patient by self questionnaire
timeFrame: 11 weeks
measure: The subjective assessment of patient acceptability questionnaires self treatment
timeFrame: 11 weeks
measure: The support type envisaged endline by the doctor
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale
Study officials:
References: