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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01535378
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : July 22, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Temporomandibular Disorders

Study Design

Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus
Study Start Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Assessment of behavioural reeducation [ Time Frame: 1 year ]
    Interest of diagnosis criteria of investigation on temporomandibular disorders.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with temporomandibular disorders

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535378

Rennes University Hospital
Rennes, Brittany, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Principal Investigator: Dominique Chauvel-Lebret Rennes University Hospital
More Information

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01535378     History of Changes
Other Study ID Numbers: 2011-A00838-33
LOC/11-06 ( Other Identifier: Rennes University Hospital (Direction of Clinical Research) )
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes