An observational study in Temporomandibular Joint Disorders and Mastication Disorder, sponsored by University of Santiago de Compostela. Completed at 1 site in Spain. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by University of Santiago de Compostela · Observational
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 216 observational studies indexed under Joint Diseases.
Browse Joint Diseases studies →University of Santiago de Compostela is the lead sponsor of 59 studies on the registry; 11 are open to participants now.
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Medical or Dental School students. Healthy young adults with fully dentate normal occlusion
Exclusion Criteria:
Pains from other origins or Orthodontics are not criteria for exclusion
OBSERVATIONAL, DIAGNOSTIC PROCEDURES. Young adults with no signs or symptoms of TMD will be assessed. The chewing function, condylar path angles and lateral guidance angles will be recorded. Maximum comfortable and unassisted jaw opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Three-Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD. Same recordings as baseline will be carried out.
Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD
Pain-intensity (0-10 VAS scale, Von Korf)
Time frame: At 3 years follow-up
Change of maximal unassited jaw opening
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.
Time frame: Baseline and 3 years follow-up
Change of condylar paths angles inclination
Alteration of parasagittal plane Axiography of condyle motion in respect Frankfort horizontal plane
Time frame: Baseline and 3-4-years follow-up (end of the study)
Alteration of lateral dental guidance angles
Angle between Frankfort plane and lateral dental anterior guidance
Time frame: Baseline and 4-years follow-up (end of the study)
Change of maximal comfortable jaw opening
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.
Time frame: Baseline and 4-years follow-up (end of the study)
Change of the habitual chewing side
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.
Time frame: Baseline and 3-4-years follow-up (end of the study)
Change of lateral deviation during maximal unassisted jaw opening
Kiesiography K7
Time frame: Baseline, 3 years follow-up
Hemimandibular retrognathia
Interincisal median midline and Angle Class on each side
Time frame: Baseline
Hemispheric dominance, asuming oposite side to handedness preference
Edinburg inventory (Oldfield)
Time frame: Baseline
Change of Life quality
SCL-90-R self-administered questionaire
Time frame: Baseline, 3 years follow-up
Plan to share: Yes — Data will be shared in a on-line appendix linked from the article in a JCR Journal.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Santiago de Compostela