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
  Purpose

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
Temporomandibular Disorders

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 32
Study Start Date: March 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with temporomandibular disorders

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535378

Contacts
Contact: Dominique Chauvel-lebret 33-2-2323-4364 dominique.lebret-chauvel@univ-rennes1.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, Brittany, France, 35033
Contact: Dominique Chauvel-Lebret    33-2-2323-4364    dominique.lebret-chauvel@univ-rennes1.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Dominique Chauvel-Lebret Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01535378     History of Changes
Other Study ID Numbers: 2011-A00838-33, LOC/11-06
Study First Received: February 14, 2012
Last Updated: March 7, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

ClinicalTrials.gov processed this record on April 17, 2014