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Altered MAstication Contribute to TMJ PAin (MAPA)

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ClinicalTrials.gov Identifier: NCT03139994
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Urbano Santana Penin, MD, DDS, PhD, University of Santiago de Compostela

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.


Condition or disease Intervention/treatment
Temporomandibular Joint Disorders Mastication Disorder Other: Diagnostic

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Diagnostic
    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.


Primary Outcome Measures :
  1. 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)

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. Change of lateral deviation during maximal unassisted jaw opening [ Time Frame: Baseline, 3 years follow-up ]
    Kiesiography K7


Other Outcome Measures:
  1. Hemimandibular retrognathia [ Time Frame: Baseline ]
    Interincisal median midline and Angle Class on each side

  2. Hemispheric dominance, asuming oposite side to handedness preference [ Time Frame: Baseline ]
    Edinburg inventory (Oldfield)

  3. Change of Life quality [ Time Frame: Baseline, 3 years follow-up ]
    SCL-90-R self-administered questionaire



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Medical or Dental School students. Healthy young adults with fully dentate normal occlusion
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139994


Contacts
Contact: Urbano Santana, Prof. 034647344093 urbano.santana@usc.es
Contact: Mª Jesús Mora, Prof. 600942464 mariajesus.mora@usc.es

Locations
Spain
University of Santiago de Compostela Recruiting
Santiago de Compostela, A Coruña, Spain, 15702
Sponsors and Collaborators
University of Santiago de Compostela
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 of Results:
Responsible Party: Urbano Santana Penin, MD, DDS, PhD, PROFESSOR, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT03139994     History of Changes
Other Study ID Numbers: 20130123
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared in a on-line appendix linked from the article in a JCR Journal.

Keywords provided by Urbano Santana Penin, MD, DDS, PhD, University of Santiago de Compostela:
occlusion
pain

Additional relevant MeSH terms:
Disease
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Pathologic Processes
Myofascial Pain Syndromes