Temporomandibular DisordersPARADYSAMNCT01535378
Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus
An observational study of Temporomandibular Disorders, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with temporomandibular disorders
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Temporomandibular Disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
Assessment of behavioural reeducation
Interest of diagnosis criteria of investigation on temporomandibular disorders.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Chauvel-Lebret, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535378
- Sponsor's protocol ID
- 2011-A00838-33
- Other IDs
- LOC/11-06
- Acronym
- PARADYSAM
- Status last verified
- Jul 2014
- First submitted
- 14 Feb 2012
- Last updated
- 22 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus
- ClinicalTrials.gov ID
- NCT01535378
- Acronym / sponsor ID
- PARADYSAM / 2011-A00838-33
- Conditions
- Temporomandibular Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with temporomandibular disorders
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Amplitude of mouth opening, mandibular deviation, joint clicking or crepitations,disc deplacement with reduction
Time frame: 1 year
Assessment of behavioural reeducation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Chauvel-Lebret principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain based on the analogical visual scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.