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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03139994
Other study ID # 20130123
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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