Computer Guided Versus Conventional TMJ Injection

Study Overview
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Brief Summary
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This study is designed to evaluate the clinical outcomes of computer-guided sodium hyaluronate injection in superior joint space in comparison to conventional injection for treatment of intra-articular TMJ disorder.

Detailed Description
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This study aimed to reveal the superiority of computer-guided TMJ injection (if found) above the conventional method from the clinician and patient point of view.

Official Title
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Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder

Conditions
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TMD

Intervention / Treatment
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* Procedure: TMJ injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Patients who would not respond to conservative treatment as the first line of treatment. Exclusion Criteria: Patients with polyarthritis or degenerative joint disease. Patients with myofascial pain. Previous history of minimally invasive or invasive treatment of TMJ. History of mandibular fracture. Lactating, pregnant or planning pregnancy women. Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space. | Procedure: TMJ injection<br>* four sodium hyaluronate injections in superior TMJ space<br>|
| Active Comparator: Group B<br>Patients treated with four conventional sodium hyaluronate injections in superior TMJ space. | Procedure: TMJ injection<br>* four sodium hyaluronate injections in superior TMJ space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of maximum unassisted mouth opening range | Opening range determined by asking the patient to gently open the mouth and measure the distance between upper and lower central incisor using an vernier digital electronic caliper. Vertical movement of the mandible corrected by adding the vertical overlap. | 6 months | 
| Comparison of modified Helkimo's clinical dysfunction index. | A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction. | 6 months | 
| Comparison of pain intensity on Visual analog scale | Patients asked to mark their TMJ-related pain level on a scale from 0 to 10, where 0 is no pain and 10 is severe pain. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedural time. | Total procedural time consumed starting from application of topical antiseptic up to the end of the procedure. | Baseline | 
| Patient convenience. | Patient convenience on a scale from 0 to 10, where 0 is highly convenient and 10 extremely intolerable. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMD