Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus (PARADYSAM)

This study is currently recruiting participants.

Verified March 2013 by Rennes University Hospital

Sponsor:

Information provided by (Responsible Party):

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT01535378

First received: February 14, 2012

Last updated: March 7, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2012

Last Updated Date

March 7, 2013

Start Date ^ICMJE

March 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Assessment of pain based on the analogical visual scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01535378 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Amplitude of mouth opening, mandibular deviation, joint clicking or crepitations,disc deplacement with reduction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluation of parafunctions as an etiological factor of dysfunctions of masticatory apparatus.
Assessment of behavioural reeducation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Interest of diagnosis criteria of investigation on temporomandibular disorders.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus

Official Title ^ICMJE

Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with temporomandibular disorders

Condition ^ICMJE

Temporomandibular Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dominique Chauvel-lebret

33-2-2323-4364

dominique.lebret-chauvel@univ-rennes1.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01535378

Other Study ID Numbers ^ICMJE

2011-A00838-33, LOC/11-06

Has Data Monitoring Committee

Not Provided

Responsible Party

Rennes University Hospital

Study Sponsor ^ICMJE

Rennes University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dominique Chauvel-Lebret

Rennes University Hospital

Information Provided By

Rennes University Hospital

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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