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OpenTrials
Completed

NCT Number: NCT03139994

Altered MAstication Contribute to TMJ PAin

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.

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Key information

Conditions

Temporomandibular Joint Disorders Bites and Stings Chemically-Induced Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Mastication Disorder Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms Stomatognathic Diseases Wounds and Injuries

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15702, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic

Other

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.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. Change of lateral deviation during maximal unassisted jaw opening

    Time frame: Baseline, 3 years follow-up

    Kiesiography K7

Other outcomes

  1. Hemimandibular retrognathia

    Time frame: Baseline

    Interincisal median midline and Angle Class on each side

  2. Hemispheric dominance, asuming oposite side to handedness preference

    Time frame: Baseline

    Edinburg inventory (Oldfield)

  3. Change of Life quality

    Time frame: Baseline, 3 years follow-up

    SCL-90-R self-administered questionaire

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study title

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

Acronym: MAPA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 4, 2017
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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