Altered MAstication Contribute to TMJ PAin
MAPA
One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2016
CompletedStudy Start
First participant enrolled
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedOctober 1, 2021
September 1, 2021
1.5 years
May 10, 2016
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD
Pain-intensity (0-10 VAS scale, Von Korf)
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.
Baseline and 3 years follow-up
Secondary Outcomes (5)
Change of condylar paths angles inclination
Baseline and 3-4-years follow-up (end of the study)
Alteration of lateral dental guidance angles
Baseline and 4-years follow-up (end of the study)
Change of maximal comfortable jaw opening
Baseline and 4-years follow-up (end of the study)
Change of the habitual chewing side
Baseline and 3-4-years follow-up (end of the study)
Change of lateral deviation during maximal unassisted jaw opening
Baseline, 3 years follow-up
Other Outcomes (3)
Hemimandibular retrognathia
Baseline
Hemispheric dominance, asuming oposite side to handedness preference
Baseline
Change of Life quality
Baseline, 3 years follow-up
Interventions
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.
Eligibility Criteria
Medical or Dental School students. Healthy young adults with fully dentate normal occlusion
You may qualify if:
- healthies
- full dentates
- normal occlusion
- One habitual chewing side
You may not qualify if:
- Severe malocclusion, dental decay, severe periodontal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15702, Spain
Related Publications (1)
Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.
PMID: 23593156RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROFESSOR
Study Record Dates
First Submitted
May 10, 2016
First Posted
May 4, 2017
Study Start
May 2, 2017
Primary Completion
October 15, 2018
Study Completion
October 30, 2018
Last Updated
October 1, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
Data will be shared in a on-line appendix linked from the article in a JCR Journal.