Occlusal Adjustment as Treatment for Chronic Orofacial Pain

July 21, 2013 updated by: Urbano Santana, University of Santiago de Compostela

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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."

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario de La Coruña
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15782
        • Facultad de Medicina y Odontología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Procedure: Occlusal adjustment
modification of occlusal surfaces
Other Names:
  • Selective grinding
  • Occlusal reshaping
  • Occlusal equilibration
  • Occlusal therapy
Placebo Comparator: B
Procedure: Placebo occlusal adjustment
Simulated modification of occlusal surfaces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
Baseline, immediately after therapy, 3 months and 6 months after therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and 6 months after therapy
Preferred Chewing Side
Time Frame: Before and 6 months after therapy
The change in the habitual chewing side of each participant across the study
Before and 6 months after therapy
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
6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Investigators

  • Principal Investigator: José López-Cedrún Cembranos, MD, DDS, PhD, Complejo Hospitalario Universitario de La Coruña
  • Study Director: Urbano Santana Penín, MD, DDS, PhD, Universidad de Santiago de Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 21, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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