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:
Rennes University Hospital
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
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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 May 22, 2013