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

NCT ID: NCT02907450

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-03-31

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.

Conditions

Dentofacial Functional Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical evaluation of the tolerance of the orthosis

Group Type: EXPERIMENTAL

TwiCare®.

Intervention Type: DEVICE

Interventions

TwiCare®.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale

Nantes, , France

Countries

France

Other Identifiers

2011-A01106-35

Identifier Type: OTHER

Identifier Source: secondary_id

BRD/11/2-W

Identifier Type: -

Identifier Source: org_study_id