Accuracy of Patient Specific Guide for TMJ Injection

TMD Clinical Trial

Official title:

Evaluation of Patient Specific Guide Accuracy for TMJ Superior Joint Space Injection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05522114
• Other study ID #: PSG-TMJ-acc.
• Status: Completed
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: August 22, 2022

Study information

• Verified date: August 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 22, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• TMD

Intervention

Procedure:
• TMJ injection using patient specific guide
Prefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Al-Azhar University.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angle of deviation	The angle (°) between the planned and actual needle measured.	1 month
Primary	Vertical displacement of needle tip	The vertical displacement of the actual needle tip in comparison to the planned one (mm).	1 month
Primary	Overall needle tip dislocation	The distance between the planned and actual needle tips (mm).	1 month