- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01535378
Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus (PARADYSAM)
July 21, 2014 updated by: Rennes University Hospital
If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and more important.
Treatment of patients presenting TMD is based on conservative and reversible therapeutics.
The behavioural reeducation of these patients which aims at decreasing their parafunctions is a treatment often performed.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Brittany
-
Rennes, Brittany, France, 35033
- Rennes University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with temporomandibular disorders
Description
Inclusion Criteria:
- Male and female over 18,
- Patient who was informed about the protocol and who did not refuse to take part in the programme,
- Patient who suffers of dysfunctions of masticatory apparatus: myofascial pain, joint clicking or crepitations, disc deplacement with reduction, mandibular limitation and/or deviation,
- Patient who presents more or less obvious parafunctions, which are associated or not to other etiologies
- Patient consulting for the 1st time for TMD
Exclusion Criteria:
- Persons over 18 who are under legal protection (guardianship), persons who are deprived of their freedom,
- Patient who is already followed in the consultation of dysfunctions of masticatory apparatus and who is under treatment,
- Patient who is under treatment of occlusal splint (not in the framework of the consultation of TMD
- Patient with pains other than orofacial pains (cephalalgia, neuralgia, vascular algia of the face, migraine),
- Patient who needs a treatment other than a behavioural reeducation (pharmacological treatment, occlusal splint , addressed to another therapist, prosthetic treatment)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of pain based on the analogical visual scale
Time Frame: 1 year
|
To know the incidence of a treatment which is unique, reversible and performed in first intention: behavioural reeducation in the evolution of clinical signs of TMD : pain; disc deplacement with reduction, limitation or mandibular deviation during mouth opening.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amplitude of mouth opening, mandibular deviation, joint clicking or crepitations,disc deplacement with reduction
Time Frame: 1 year
|
Evaluation of parafunctions as an etiological factor of dysfunctions of masticatory apparatus.
|
1 year
|
|
Assessment of behavioural reeducation
Time Frame: 1 year
|
Interest of diagnosis criteria of investigation on temporomandibular disorders.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dominique Chauvel-Lebret, Rennes University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Study Registration Dates
First Submitted
February 14, 2012
First Submitted That Met QC Criteria
February 14, 2012
First Posted (Estimate)
February 17, 2012
Study Record Updates
Last Update Posted (Estimate)
July 22, 2014
Last Update Submitted That Met QC Criteria
July 21, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A00838-33
- LOC/11-06 (Other Identifier: Rennes University Hospital (Direction of Clinical Research))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.