Altered MAstication Contribute to TMJ PAin (MAPA)

September 30, 2021 updated by: Urbano Santana Penin, MD, DDS, PhD, University of Santiago de Compostela

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

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15702
        • University of Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical or Dental School students. Healthy young adults with fully dentate normal occlusion

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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)
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.
Baseline and 3-4-years follow-up (end of the study)
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
Change of Life quality
Time Frame: Baseline, 3 years follow-up
SCL-90-R self-administered questionaire
Baseline, 3 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

October 15, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared in a on-line appendix linked from the article in a JCR Journal.

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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