Computer Guided Versus Conventional TMJ Injection

TMD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288647
• Other study ID #: CG-HA-TMJ-inj.
• Status: Completed
• Phase: N/A
• Start date: December 24, 2019
• Est. completion date: October 11, 2021

Study information

• Verified date: March 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 11, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• TMD

Intervention

Procedure:
• TMJ injection
four sodium hyaluronate injections in superior TMJ space

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Al-Azhar University.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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