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Occlusal Adjustment as Treatment for Chronic Orofacial Pain

This study has been completed.
Sponsor:
Information provided by:
University of Santiago de Compostela
ClinicalTrials.gov Identifier:
NCT00899717
First received: May 11, 2009
Last updated: April 7, 2010
Last verified: August 2009
History of Changes

May 11, 2009
April 7, 2010
May 2009
June 2009   (final data collection date for primary outcome measure)
Visual Analogic Scale for pain intensity (0-10) [ 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 ]
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
  • SCL-90-R quality of life questionary [ Time Frame: Before and 6 months after therapy ] [ Designated as safety issue: No ]
  • Preferred chewing side [ Time Frame: Before and 6 months after therapy ] [ Designated as safety issue: No ]
  • Condylar paths (axiography) [ Time Frame: Before and 6 months after therapy ] [ Designated as safety issue: No ]
  • Lateral dental guidance angle (Gnatography) [ Time Frame: Before and during therapy ] [ Designated as safety issue: No ]
  • Maximum comfortable 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 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 ]
  • Handedness [ Time Frame: Determination before therapy ] [ Designated as safety issue: No ]
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
20
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-Penin/Universidad de Santiago de Compostela: professor and chair, Universidad de 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
August 2009

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