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

Dentofacial Functional Disorder Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentofacial Functional Disorder
• Jaw Abnormalities
• Malocclusion

• NCT number: NCT02907450
• Study type: Interventional
• Source: Nantes University Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Completion date: March 2015