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OpenTrials
Completed

NCT Number: NCT05522114

Accuracy of Patient Specific Guide for TMJ Injection

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

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Key information

Conditions

TMD

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Al-Azhar University.

Cairo, 11884, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TMJ injection using patient specific guide

Procedure

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.

Primary outcomes

  1. Angle of deviation

    Time frame: 1 month

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

  2. Vertical displacement of needle tip

    Time frame: 1 month

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

  3. Overall needle tip dislocation

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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