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Completed

NCT Number: NCT05288647

Computer Guided Versus Conventional TMJ Injection

This study is designed to evaluate the clinical outcomes of computer-guided sodium hyaluronate injection in superior joint space in comparison to conventional injection for treatment of intra-articular TMJ disorder.

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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

This study aimed to reveal the superiority of computer-guided TMJ injection (if found) above the conventional method from the clinician and patient point of view.

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

  • Patients with polyarthritis or degenerative joint disease.
  • Patients with myofascial pain.
  • Previous history of minimally invasive or invasive treatment of TMJ.
  • History of mandibular fracture.
  • Lactating, pregnant or planning pregnancy women.
  • Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Treatment and study plan

TMJ injection

Procedure

four sodium hyaluronate injections in superior TMJ space

Primary outcomes

  1. Comparison of maximum unassisted mouth opening range

    Time frame: 6 months

    Opening range determined by asking the patient to gently open the mouth and measure the distance between upper and lower central incisor using an vernier digital electronic caliper. Vertical movement of the mandible corrected by adding the vertical overlap.

  2. Comparison of modified Helkimo's clinical dysfunction index.

    Time frame: 6 months

    A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.

  3. Comparison of pain intensity on Visual analog scale

    Time frame: 6 months

    Patients asked to mark their TMJ-related pain level on a scale from 0 to 10, where 0 is "no pain" and 10 is "severe pain".

Secondary outcomes

  1. Total procedural time.

    Time frame: Baseline

    Total procedural time consumed starting from application of topical antiseptic up to the end of the procedure.

  2. Patient convenience.

    Time frame: Baseline

    Patient convenience on a scale from "0" to "10", where "0" is highly convenient and "10" extremely intolerable.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2022
Registry last updated
Mar 31, 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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