Clinical Trial: TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
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.
Detailed Summary:
Sponsor: Nantes University Hospital
Current Primary Outcome: No appearance of more than one injury that can not be attributed to causes other than the orthosis [ Time Frame: 11 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview) [ Time Frame: 11 weeks ]
- The subjective assessment of the compliance of wearing the brace by patient by self questionnaire [ Time Frame: 11 weeks ]
- The subjective assessment of patient acceptability questionnaires self treatment [ Time Frame: 11 weeks ]
- The support type envisaged endline by the doctor [ Time Frame: 11 weeks ]
Original Secondary Outcome: Same as current
Information By: Nantes University Hospital
Dates:
Date Received: September 9, 2016
Date Started: October 2012
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016
