ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01535378
Date of registration:	14/02/2012
Prospective Registration:	Yes
Primary sponsor:	Rennes University Hospital
Public title:	Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus PARADYSAM
Scientific title:	Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus
Date of first enrolment:	March 2012
Target sample size:	32
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT01535378
Study type:	Observational
Study design:	Observational Model: Case-Only, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Dominique Chauvel-Lebret
Address:
Telephone:
Email:
Affiliation:	Rennes University Hospital

Key inclusion & exclusion 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)

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Temporomandibular Disorders

Intervention(s)

Primary Outcome(s)

Assessment of pain based on the analogical visual scale [Time Frame: 1 year]

Secondary Outcome(s)

Assessment of behavioural reeducation [Time Frame: 1 year]

Amplitude of mouth opening, mandibular deviation, joint clicking or crepitations,disc deplacement with reduction [Time Frame: 1 year]

Secondary ID(s)

2011-A00838-33

LOC/11-06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.