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Clinical Trials/NCT05522114
NCT05522114
Completed
Not Applicable

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

Al-Azhar University1 site in 1 country5 target enrollmentApril 19, 2022
ConditionsTMD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
TMD
Sponsor
Al-Azhar University
Enrollment
5
Locations
1
Primary Endpoint
Vertical displacement of needle tip
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 19, 2022
End Date
August 22, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AbdElKader Ahmed Hyder Mohamed

Principal Investigator

Al-Azhar University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Vertical displacement of needle tip

Time Frame: 1 month

The vertical displacement of the actual needle tip in comparison to the planned one (mm).

Overall needle tip dislocation

Time Frame: 1 month

The distance between the planned and actual needle tips (mm).

Angle of deviation

Time Frame: 1 month

The angle (°) between the planned and actual needle measured.

Study Sites (1)

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