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

Study Overview

• Status: Completed
• Conditions: Dentofacial Functional Disorder
• Intervention / Treatment: Device: TwiCare®.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical evaluation of the tolerance of the orthosis	Device: TwiCare®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No appearance of more than one injury that can not be attributed to causes other than the orthosis	11 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BRD/11/2-W; 2011-A01106-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO