Altered MAstication Contribute to TMJ PAin

Temporomandibular Joint Disorders Clinical Trial

— MAPA  

Official title:

One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139994
• Other study ID #: 20130123
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: September 2021
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 30, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Mastication Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	University of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Santana-Mora U, López-Cedrún J, Mora MJ, Otero XL, Santana-Penín U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemimandibular retrognathia	Interincisal median midline and Angle Class on each side	Baseline
Other	Hemispheric dominance, asuming oposite side to handedness preference	Edinburg inventory (Oldfield)	Baseline
Other	Change of Life quality	SCL-90-R self-administered questionaire	Baseline, 3 years follow-up
Primary	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
Primary	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	Change of condylar paths angles inclination	Alteration of parasagittal plane Axiography of condyle motion in respect Frankfort horizontal plane	Baseline and 3-4-years follow-up (end of the study)
Secondary	Alteration of lateral dental guidance angles	Angle between Frankfort plane and lateral dental anterior guidance	Baseline and 4-years follow-up (end of the study)
Secondary	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.	Baseline and 4-years follow-up (end of the study)
Secondary	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.	Baseline and 3-4-years follow-up (end of the study)
Secondary	Change of lateral deviation during maximal unassisted jaw opening	Kiesiography K7	Baseline, 3 years follow-up