Occlusal Adjustment as Treatment for Chronic Orofacial Pain

University of Santiago de Compostela21 enrolled

Overview

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."

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Temporomandibular Joint Disorders Orofacial Pain

Interventions

Occlusal adjustmentPROCEDURE

modification of occlusal surfaces

Placebo occlusal adjustmentPROCEDURE

Simulated modification of occlusal surfaces

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Complejo Hospitalario Universitario de La Coruña

A Coruña, La Coruña, Spain

Facultad de Medicina y Odontología

Santiago de Compostela, La Coruña, Spain

Outcomes

Primary Outcomes

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"

Time frame: Baseline, immediately after therapy, 3 months and 6 months after therapy

Secondary Outcomes

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.

Time frame: Before and 6 months after therapy

Preferred Chewing Side

The change in the habitual chewing side of each participant across the study

Time frame: Before and 6 months after therapy

Maximum Mouth Opening (mm)

Maximum voluntary unassisted mouth opening

Time frame: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up

Condylar Path Angles

Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.

Time frame: Baseline

Data from ClinicalTrials.gov

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