Occlusal Adjustment as Treatment for Chronic Orofacial Pain

NCT ID: NCT00899717

Last Updated: 2013-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-04-30

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."

Conditions

Temporomandibular Joint Disorders; Orofacial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Group Type: EXPERIMENTAL

Occlusal adjustment

Intervention Type: PROCEDURE

modification of occlusal surfaces

B

Group Type: PLACEBO_COMPARATOR

Placebo occlusal adjustment

Intervention Type: PROCEDURE

Simulated modification of occlusal surfaces

Interventions

Occlusal adjustment

modification of occlusal surfaces

Intervention Type: PROCEDURE

Placebo occlusal adjustment

Simulated modification of occlusal surfaces

Intervention Type: PROCEDURE

Other Intervention Names

Selective grinding; Occlusal reshaping; Occlusal equilibration; Occlusal therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Urbano Santana

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José López-Cedrún Cembranos, MD, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de La Coruña

Urbano Santana Penín, MD, DDS, PhD

Role: STUDY_DIRECTOR

Universidad de Santiago de Compostela

Locations

Complejo Hospitalario Universitario de La Coruña

A Coruña, La Coruña, Spain

Facultad de Medicina y Odontología

Santiago de Compostela, La Coruña, Spain

Countries

Spain

Other Identifiers

2009/017

Identifier Type: -

Identifier Source: org_study_id