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Occlusal Adjustment as Treatment for Chronic Orofacial Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00899717
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 16, 2013
Last Update Posted : July 26, 2013
Information provided by (Responsible Party):
Urbano Santana, University of Santiago de Compostela

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Orofacial Pain Procedure: Occlusal adjustment Procedure: Placebo occlusal adjustment Phase 1 Phase 2

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."

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study
Study Start Date : May 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00899717

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Facultad de Medicina y Odontología
Santiago de Compostela, La Coruña, Spain, 15782
Complejo Hospitalario Universitario de La Coruña
La Coruña, Spain, 15006
Sponsors and Collaborators
University of Santiago de Compostela
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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
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Responsible Party: Urbano Santana, Prof., University of Santiago de Compostela Identifier: NCT00899717    
Other Study ID Numbers: 2009/017
First Posted: May 12, 2009    Key Record Dates
Results First Posted: July 16, 2013
Last Update Posted: July 26, 2013
Last Verified: July 2013
Keywords provided by Urbano Santana, University of Santiago de Compostela:
Temporomandibular Joint Disorders (TMD)
Orofacial pain
Limited mouth opening
Craniomandibular dysfunction syndrome
Preferred chewing side
Occlusal adjustment
Selective grinding
Costen's Syndrome
Myofascial pain
TMD treatment
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Facial Pain
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Neurologic Manifestations
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents