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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

May 11, 2009
July 21, 2013
May 2009
June 2009   (final data collection date for primary outcome measure)
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"
Visual Analogic Scale for pain intensity (0-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899717 on ClinicalTrials.gov Archive Site
  • 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.
Maximum mouth opening (mm) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Occlusal Adjustment as Treatment for Chronic Orofacial Pain
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.

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."

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Temporomandibular Joint Disorders
  • Orofacial Pain
  • Procedure: Occlusal adjustment
    modification of occlusal surfaces
    Other Names:
    • Selective grinding
    • Occlusal reshaping
    • Occlusal equilibration
    • Occlusal therapy
  • Procedure: Placebo occlusal adjustment
    Simulated modification of occlusal surfaces
  • Experimental: A
    Intervention: Procedure: Occlusal adjustment
  • Placebo Comparator: B
    Intervention: Procedure: Placebo occlusal adjustment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
April 2010
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00899717
2009/017
Yes
Urbano Santana, University of Santiago de Compostela
University of Santiago de Compostela
Not Provided
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
University of Santiago de Compostela
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP