- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139994
Altered MAstication Contribute to TMJ PAin (MAPA)
One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain
The cause of temporomandibular joint disorders remains unknown. It is considered multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has been showed an association: a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the symptomatic side. This finding argues the possibility of causation of some of these characteristics. This double blind longitudinal study aims to assess if the presence of one habitual chewing side could contribute to temporomandibular joint disorders over time.
Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one chewing side (observed and interview); with steeper condylar path and lower lateral guidance angles will be considered consistent one side chewers, and this side will be considered more susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
A Coruña
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Santiago de Compostela, A Coruña, Spain, 15702
- University of Santiago de Compostela
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- healthies
- full dentates
- normal occlusion
- One habitual chewing side
Exclusion Criteria:
- Severe malocclusion, dental decay, severe periodontal disease.
Pains from other origins or Orthodontics are not criteria for exclusion
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD
Time Frame: At 3 years follow-up
|
Pain-intensity (0-10 VAS scale, Von Korf)
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At 3 years follow-up
|
Change of maximal unassited jaw opening
Time Frame: Baseline and 3 years follow-up
|
Maximum unassisted jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge.
Up 38 in females and up 40 mm in males are considered limited.
|
Baseline and 3 years follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of condylar paths angles inclination
Time Frame: Baseline and 3-4-years follow-up (end of the study)
|
Alteration of parasagittal plane Axiography of condyle motion in respect Frankfort horizontal plane
|
Baseline and 3-4-years follow-up (end of the study)
|
Alteration of lateral dental guidance angles
Time Frame: Baseline and 4-years follow-up (end of the study)
|
Angle between Frankfort plane and lateral dental anterior guidance
|
Baseline and 4-years follow-up (end of the study)
|
Change of maximal comfortable jaw opening
Time Frame: Baseline and 4-years follow-up (end of the study)
|
Maximum jaw opening or interincisal distance (from edge to edge) measured by a Boley gauge.
Up 38 in females and up 40 mm in males are considered limited.
|
Baseline and 4-years follow-up (end of the study)
|
Change of the habitual chewing side
Time Frame: Baseline and 3-4-years follow-up (end of the study)
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Determining the habitual chewing side by direct observation using chewing gum, First cicle, and subsequent cicles (7 or over of 10 cicles), interview (used one habitual chewing side?: 1, no, alternate; 2, yes, right; 3, yes, left; 4, I don't know) and kinesiography.
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Baseline and 3-4-years follow-up (end of the study)
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Change of lateral deviation during maximal unassisted jaw opening
Time Frame: Baseline, 3 years follow-up
|
Kiesiography K7
|
Baseline, 3 years follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemimandibular retrognathia
Time Frame: Baseline
|
Interincisal median midline and Angle Class on each side
|
Baseline
|
Hemispheric dominance, asuming oposite side to handedness preference
Time Frame: Baseline
|
Edinburg inventory (Oldfield)
|
Baseline
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Change of Life quality
Time Frame: Baseline, 3 years follow-up
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SCL-90-R self-administered questionaire
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Baseline, 3 years follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Urbano Santana-Mora, PhD, University of Santiago de Compostela. Spain
- Study Chair: Urbano Santana, Prof., University of Santiago de Compostela. Spain
- Principal Investigator: Mª Jesús Mora, University of Santiago de Compostela. Spain
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20130123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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