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Completed

NCT Number: NCT00899717

Occlusal Adjustment as Treatment for Chronic Orofacial Pain

The purpose of this study is to determine whether occlusal adjustment by selective grinding and/or occlusal addition is an effective treatment of chronic temporomandibular joint disorders.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Complejo Hospitalario Universitario de La Coruña, A Coruña, La Coruña, Spain

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About this study

Temporomandibular disorders (TMD) are very common disorders in daily dentistry and oral and maxillofacial practice. The key symptoms are jaw joint pain and limited mouth opening. Other than trauma, the causes remain unknown; consequently, there are no treatments based on specific etiologies. In our experience, patients can usually receive beneficial occlusal adjustments if these are carefully planned and performed in two steps: (1) elimination of premature contacts, which reduces loads in the temporomandibular joints, and (2) individualized remodeling of lateral anterior guidance to facilitate unilateral alternate chewing. The study will use stratified blocking randomization to blindly assign patients to the real or placebo treatment groups in order to evaluate the null hypothesis (H0) that "Occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth opening in TMD patients."

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • People suitable for inclusion in the study are full dentate patients
  • Aged between 18 and 65 years
  • Patients with chronic TMD pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated

Exclusion criteria

  • Pregnancy
  • Trauma
  • Previous TMJ surgery
  • Patient refusal to consent to participate in the study or significant concerns about the study
  • Limited collaboration
  • Concurrent active treatment with orthodontics, and active periodontal disease

Treatment and study plan

Occlusal adjustment

Procedure

modification of occlusal surfaces

Other names: Selective grinding, Occlusal reshaping, Occlusal equilibration, Occlusal therapy

Placebo occlusal adjustment

Procedure

Simulated modification of occlusal surfaces

Primary outcomes

  1. Visual Analogic Scale for Pain Intensity (0-10)

    Time frame: Baseline, immediately after therapy, 3 months and 6 months after therapy

    The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0="No pain" and 10="Worst imaginable pain"

Secondary outcomes

  1. Symptom Checklist-90-Revised (SCL-90-R®)

    Time frame: Before and 6 months after therapy

    Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.

  2. Preferred Chewing Side

    Time frame: Before and 6 months after therapy

    The change in the habitual chewing side of each participant across the study

  3. Maximum Mouth Opening (mm)

    Time frame: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up

    Maximum voluntary unassisted mouth opening

  4. Condylar Path Angles

    Time frame: Baseline

    Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study title

Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
May 12, 2009
Registry last updated
Jul 26, 2013

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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