Clinical trial NCT03139994: Altered MAstication Contribute to TMJ PAin
Official title: One Habitual Chewing Side May Contribute to Chronic Temporomandibular Joint Disorder Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disorders
Mastication Disorder
Keywords: occlusion
pain
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical or Dental School students. Healthy young adults with fully dentate normal occlusion

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.


Eligibility 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

Primary outcomes:
measure: Presence or not of symptoms of temporomandibular joint disorders according to DC/TMD
timeFrame: At 3 years follow-up
measure: Change of maximal unassited jaw opening
timeFrame: Baseline and 3 years follow-up
Secondary outcomes:
measure: Change of condylar paths angles inclination
timeFrame: Baseline and 3-4-years follow-up (end of the study)
measure: Alteration of lateral dental guidance angles
timeFrame: Baseline and 4-years follow-up (end of the study)
measure: Change of maximal comfortable jaw opening
timeFrame: Baseline and 4-years follow-up (end of the study)
measure: Change of the habitual chewing side
timeFrame: Baseline and 3-4-years follow-up (end of the study)
measure: Change of lateral deviation during maximal unassisted jaw opening
timeFrame: Baseline, 3 years follow-up
Other outcomes:
measure: Hemimandibular retrognathia
timeFrame: Baseline
measure: Hemispheric dominance, asuming oposite side to handedness preference
timeFrame: Baseline
measure: Change of Life quality
timeFrame: Baseline, 3 years follow-up
Locations:
city: Santiago de Compostela
country: Spain
facility: University of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela. Spain
name: Urbano Santana-Mora, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Santiago de Compostela. Spain
name: Urbano Santana, Prof.
role: STUDY_CHAIR
affiliation: University of Santiago de Compostela. Spain
name: Mª Jesús Mora
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.