Occlusal Adjustment as Treatment for Chronic Orofacial Pain

• ClinicalTrials.gov Identifier: NCT00899717
• Recruitment Status: Completed
• First Posted: May 12, 2009
• Results First Posted: July 16, 2013
• Last Update Posted: July 26, 2013
• Sponsor: University of Santiago de Compostela
• Information provided by (Responsible Party): Urbano Santana, University of Santiago de Compostela

Study Description

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."

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Urbano Santana, Prof., University of Santiago de Compostela
• ClinicalTrials.gov Identifier: NCT00899717 History of Changes
• Other Study ID Numbers: 2009/017
• First Posted: May 12, 2009
• 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; 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; Signs and Symptoms; Salicylic Acid; Anti-Infective Agents; Antifungal Agents; Keratolytic Agents; Dermatologic Agents