NCT03139994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

May 10, 2016

Last Update Submit

September 30, 2021

Conditions

Keywords

occlusionpain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Change of condylar paths angles inclination

    Baseline and 3-4-years follow-up (end of the study)

  • Alteration of lateral dental guidance angles

    Baseline and 4-years follow-up (end of the study)

  • Change of maximal comfortable jaw opening

    Baseline and 4-years follow-up (end of the study)

  • Change of the habitual chewing side

    Baseline and 3-4-years follow-up (end of the study)

  • Change of lateral deviation during maximal unassisted jaw opening

    Baseline, 3 years follow-up

Other Outcomes (3)

  • Hemimandibular retrognathia

    Baseline

  • Hemispheric dominance, asuming oposite side to handedness preference

    Baseline

  • Change of Life quality

    Baseline, 3 years follow-up

Interventions

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.

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Medical or Dental School students. Healthy young adults with fully dentate normal occlusion

You may qualify if:

  • healthies
  • full dentates
  • normal occlusion
  • One habitual chewing side

You may not qualify if:

  • Severe malocclusion, dental decay, severe periodontal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15702, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Temporomandibular Joint DisordersBites and StingsPain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPoisoningChemically-Induced DisordersWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Urbano Santana-Mora, PhD

    University of Santiago de Compostela. Spain

    PRINCIPAL INVESTIGATOR
  • Urbano Santana, Prof.

    University of Santiago de Compostela. Spain

    STUDY CHAIR
  • Mª Jesús Mora

    University of Santiago de Compostela. Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 4, 2017

Study Start

May 2, 2017

Primary Completion

October 15, 2018

Study Completion

October 30, 2018

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Data will be shared in a on-line appendix linked from the article in a JCR Journal.

Locations