Computer Guided Versus Conventional TMJ Injection

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05288647
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.6
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
TMD	Procedure: TMJ injection	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder
• Actual Study Start Date: Dec 24, 2019
• Actual Primary Completion Date: Apr 7, 2021
• Actual Study Completion Date: Oct 11, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Comparison of maximum unassisted mouth opening range [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. [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 [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 Outcome Measures

1. Total procedural time. [Baseline]

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

2. Patient convenience. [Baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Al-Azhar University.	Cairo		Egypt	11884

Sponsors and Collaborators

• Al-Azhar University

Investigators

• Principal Investigator: AbdElKader A Hyder, MSc, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
• Study Director: Wael A ElMohandes, PhD, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
• Study Director: Bahaa El-Din A Tawfik, PhD, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Krause M, Dörfler HM, Kruber D, Hümpfner-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.
• 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.
• Steenks MH, Türp 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.

• Responsible Party: AbdElKader Ahmed Hyder Mohamed, Principal Investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05288647
• Other Study ID Numbers: CG-HA-TMJ-inj.
• First Posted: Mar 21, 2022
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AbdElKader Ahmed Hyder Mohamed, Principal Investigator, Al-Azhar University: TMD

Study Results

No Results Posted as of Mar 31, 2022