Occlusal Adjustment as Treatment for Chronic Orofacial Pain

Phase 1

Completed

• Conditions: Temporomandibular Joint Disorders; Orofacial Pain
• Interventions: Procedure: Occlusal adjustment; Procedure: Placebo occlusal adjustment

• Registration Number: NCT00899717
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Primary Completion: 2009-06
• Study Completion: 2010-04
• Results First Submitted: 2013-04-10
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-13
• Results First Posted: 2013-07-16
• Last Update Submitted: 2013-07-21
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Occlusal adjustment	-
B	Placebo occlusal adjustment	-

Primary Outcome Measures

Name	Time	Method
Visual Analogic Scale for Pain Intensity (0-10)	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

Name	Time	Method
Symptom Checklist-90-Revised (SCL-90-R®)	Before and 6 months after therapy	Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.
Preferred Chewing Side	Before and 6 months after therapy	The change in the habitual chewing side of each participant across the study
Maximum Mouth Opening (mm)	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
Condylar Path Angles	Baseline	Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.

Trial Locations

Locations (2)

Complejo Hospitalario Universitario de La Coruña; 🇪🇸 La Coruña, Spain

Facultad de Medicina y Odontología; 🇪🇸 Santiago de Compostela, La Coruña, Spain