Accuracy of Patient Specific Guide for TMJ Injection

Not Applicable

Completed

• Conditions: TMD

• Registration Number: NCT05522114
• Lead Sponsor: Al-Azhar University

Brief Summary

This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.

Detailed Description

The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.

Study Timeline

• Study Start: 2022-04-19
• Status Verified: 2022-08
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-22
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-29
• Last Update Submitted: 2022-08-29
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Lactating, pregnant or planning pregnancy women.
• Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vertical displacement of needle tip	1 month	The vertical displacement of the actual needle tip in comparison to the planned one (mm).
Overall needle tip dislocation	1 month	The distance between the planned and actual needle tips (mm).
Angle of deviation	1 month	The angle (°) between the planned and actual needle measured.

Trial Locations

Locations (1)

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