Computer Guided Versus Conventional TMJ Injection

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

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.

Study Overview

• Status: Completed
• Conditions: TMD
• Intervention / Treatment: Procedure: TMJ injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space.	Procedure: TMJ injection; four sodium hyaluronate injections in superior TMJ space
Active Comparator: Group B; Patients treated with four conventional sodium hyaluronate injections in superior TMJ space.	Procedure: TMJ injection; four sodium hyaluronate injections in superior TMJ space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of maximum unassisted mouth opening range	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.	6 months
Comparison of modified Helkimo's clinical dysfunction index.	A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.	6 months
Comparison of pain intensity on Visual analog scale	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".	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedural time.	Total procedural time consumed starting from application of topical antiseptic up to the end of the procedure.	Baseline
Patient convenience.	Patient convenience on a scale from "0" to "10", where "0" is highly convenient and "10" extremely intolerable.	Baseline

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• Krause M, Dorfler HM, Kruber D, Humpfner-Hierl H, Hierl T. Template-based temporomandibular joint puncturing and access in minimally invasive TMJ surgery (MITMJS) - a technical note and first clinical results. Head Face Med. 2019 Apr 2;15(1):10. doi: 10.1186/s13005-019-0194-8. Erratum In: Head Face Med. 2019 Jun 18;15(1):14.
• Steenks MH, Turp JC, de Wijer A. Reliability and Validity of the Diagnostic Criteria for Temporomandibular Disorders Axis I in Clinical and Research Settings: A Critical Appraisal. J Oral Facial Pain Headache. 2018 Winter;32(1):7-18. doi: 10.11607/ofph.1704.
• Rani S, Pawah S, Gola S, Bakshi M. Analysis of Helkimo index for temporomandibular disorder diagnosis in the dental students of Faridabad city: A cross-sectional study. J Indian Prosthodont Soc. 2017 Jan-Mar;17(1):48-52. doi: 10.4103/0972-4052.194941.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2019
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: TMD
• Other Study ID Numbers: CG-HA-TMJ-inj.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No