Accuracy of Patient Specific Guide for TMJ Injection

August 29, 2022 updated by: AbdElKader Ahmed Hyder Mohamed, Al-Azhar University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11884
        • Faculty of Dentistry, Al-Azhar University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patient specific guided injection
Patients treated with HA injection in TMJ using PSG and the accuracy evaluated using MSCT.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 19, 2022

Primary Completion (ACTUAL)

August 3, 2022

Study Completion (ACTUAL)

August 22, 2022

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (ACTUAL)

August 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSG-TMJ-acc.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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