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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01535378
Other study ID # 2011-A00838-33
Secondary ID LOC/11-06
Status Completed
Phase N/A
First received February 14, 2012
Last updated July 21, 2014
Start date March 2012

Study information

Verified date July 2014
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Rennes University Hospital Rennes Brittany

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of pain based on the analogical visual scale 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 No
Secondary Amplitude of mouth opening, mandibular deviation, joint clicking or crepitations,disc deplacement with reduction Evaluation of parafunctions as an etiological factor of dysfunctions of masticatory apparatus. 1 year No
Secondary Assessment of behavioural reeducation Interest of diagnosis criteria of investigation on temporomandibular disorders. 1 year No
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