Occlusal Adjustment as Treatment for Chronic Orofacial Pain

Temporomandibular Joint Disorders Clinical Trial

Official title:

Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899717
• Other study ID #: 2009/017
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 11, 2009
• Last updated: July 21, 2013
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: July 2013
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Orofacial Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Occlusal adjustment
modification of occlusal surfaces
• Placebo occlusal adjustment
Simulated modification of occlusal surfaces

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de La Coruña	La Coruña
Spain	Facultad de Medicina y Odontología	Santiago de Compostela	La Coruña

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogic Scale for Pain Intensity (0-10)	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"	Baseline, immediately after therapy, 3 months and 6 months after therapy	No
Secondary	Symptom Checklist-90-Revised (SCL-90-R®)	Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.	Before and 6 months after therapy	No
Secondary	Preferred Chewing Side	The change in the habitual chewing side of each participant across the study	Before and 6 months after therapy	No
Secondary	Maximum Mouth Opening (mm)	Maximum voluntary unassisted mouth opening	6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up	No
Secondary	Condylar Path Angles	Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.	Baseline	No