Occlusal Adjustment as Treatment for Chronic Orofacial Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Temporomandibular Joint Disorders, Orofacial Pain

Intervention / Treatment
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* Procedure: Occlusal adjustment
* Procedure: Placebo occlusal adjustment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Procedure: Occlusal adjustment<br>* modification of occlusal surfaces<br>* Other names: Occlusal therapy;|
| Placebo Comparator: B<br> | Procedure: Placebo occlusal adjustment<br>* Simulated modification of occlusal surfaces<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Preferred Chewing Side | The change in the habitual chewing side of each participant across the study | Before and 6 months after therapy | 
| 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 | 
| Condylar Path Angles | Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMD, Pain, Temporomandibular Joint Disorders (TMD), Orofacial pain, Limited mouth opening, Craniomandibular dysfunction syndrome, Axiography, Gnatography, Preferred chewing side, Occlusal adjustment, Selective grinding, Handedness, Bruxism, Costen's Syndrome, Myofascial pain, TMD treatment