Computer Guided Versus Conventional TMJ Injection

Not Applicable

Completed

• Conditions: TMD
• Interventions: Procedure: TMJ injection

• Registration Number: NCT05288647
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-12-24
• Primary Completion: 2021-04-07
• Study Completion: 2021-10-11
• Status Verified: 2022-03
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-11
• Last Update Submitted: 2022-03-18
• Study First Posted: 2022-03-21
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	TMJ injection	Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space.
Group B	TMJ injection	Patients treated with four conventional sodium hyaluronate injections in superior TMJ space.

Primary Outcome Measures

Name	Time	Method
Comparison of maximum unassisted mouth opening range	6 months	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.
Comparison of modified Helkimo's clinical dysfunction index.	6 months	A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.
Comparison of pain intensity on Visual analog scale	6 months	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".

Secondary Outcome Measures

Name	Time	Method
Patient convenience.	Baseline	Patient convenience on a scale from "0" to "10", where "0" is highly convenient and "10" extremely intolerable.
Total procedural time.	Baseline	Total procedural time consumed starting from application of topical antiseptic up to the end of the procedure.

Trial Locations

Locations (1)

Faculty of Dentistry, Al-Azhar University.; 🇪🇬 Cairo, Egypt