TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis

Nantes University Hospital (NUH)

Status

Completed

Conditions

Dentofacial Functional Disorder

Treatments

Device: TwiCare®.

Study type

Interventional

Funder types

Other

Identifiers

NCT02907450

BRD/11/2-W

2011-A01106-35 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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