Altered MAstication Contribute to TMJ PAin (MAPA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03139994|
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : October 15, 2018
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|
|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|
- 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.
- 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)
- 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.
- 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
- 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
- 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.
- 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.
- Change of lateral deviation during maximal unassisted jaw opening [ Time Frame: Baseline, 3 years follow-up ]Kiesiography K7
- Hemimandibular retrognathia [ Time Frame: Baseline ]Interincisal median midline and Angle Class on each side
- Hemispheric dominance, asuming oposite side to handedness preference [ Time Frame: Baseline ]Edinburg inventory (Oldfield)
- Change of Life quality [ Time Frame: Baseline, 3 years follow-up ]SCL-90-R self-administered questionaire
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
|Contact: Urbano Santana, Prof.||firstname.lastname@example.org|
|Contact: Mª Jesús Mora, Prof.||email@example.com|
|University of Santiago de Compostela||Recruiting|
|Santiago de Compostela, A Coruña, Spain, 15702|
|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|