Occlusal Adjustment as Treatment for Chronic Orofacial Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Urbano Santana, University of Santiago de Compostela
ClinicalTrials.gov Identifier:
NCT00899717
First received: May 11, 2009
Last updated: July 21, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Temporomandibular Joint Disorders
Orofacial Pain
Procedure: Occlusal adjustment
Procedure: Placebo occlusal adjustment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study

Resource links provided by NLM:


Further study details as provided by University of Santiago de Compostela:

Primary Outcome Measures:
  • Visual Analogic Scale for Pain Intensity (0-10) [ Time Frame: Baseline, immediately after therapy, 3 months and 6 months after therapy ] [ Designated as safety issue: No ]
    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:
  • Symptom Checklist-90-Revised (SCL-90-R®) [ Time Frame: Before and 6 months after therapy ] [ Designated as safety issue: No ]
    Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.

  • Preferred Chewing Side [ Time Frame: Before and 6 months after therapy ] [ Designated as safety issue: No ]
    The change in the habitual chewing side of each participant across the study

  • 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 ] [ Designated as safety issue: No ]
    Maximum voluntary unassisted mouth opening

  • Condylar Path Angles [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.


Enrollment: 21
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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."

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899717

Locations
Spain
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
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
  More Information

No publications provided

Responsible Party: Urbano Santana, Prof., University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT00899717     History of Changes
Other Study ID Numbers: 2009/017
Study First Received: May 11, 2009
Results First Received: April 10, 2013
Last Updated: July 21, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Santiago de Compostela:
Temporomandibular Joint Disorders (TMD)
Orofacial pain
Limited mouth opening
Craniomandibular dysfunction syndrome
Axiography
Gnatography
Preferred chewing side
Occlusal adjustment
Selective grinding
Handedness
Bruxism
TMD
Costen's Syndrome
Myofascial pain
TMD treatment
Pain

Additional relevant MeSH terms:
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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 20, 2014