TolTwiCare : Qualitative Evaluation Routine Care From Pri... | NCT02907450

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

NCT02907450

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Sep 20, 2016Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Dentofacial Functional Disorder

Interventions

TwiCare®.

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-A01106-35	Other Identifier	ANSM

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Sep 9, 2016

First Submission Date that Met QC Criteria

Sep 14, 2016

First Posted Date

Sep 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2016

Last Update Posted Date

Sep 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
Clinical evaluation of the tolerance of the orthosis	Experimental		Device: TwiCare®.

Name	Type	Description	Arm Group Labels	Other Names
TwiCare®.	Device		Clinical evaluation of the tolerance of the orthosis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale		Nantes		44093	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided