Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint

Not Applicable

Completed

• Conditions: Temporomandibular Disorder

• Registration Number: NCT06667791
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point.

Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-03
• Primary Completion: 2024-08-21
• Status Verified: 2024-10
• Study Completion: 2024-10-24
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1. Patients diagnosed with internal derangement according to Wilkins stage I and II.
• Patients who would not respond to conservative treatment as a first line of treatment.

Exclusion Criteria

• Patients with Wilkins stage III, IV, V.
• History of mandibular fracture.
• Lactating, pregnant or planning pregnancy women.
• Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in TMJ dysfunction	Baseline, 1 month, and 3 months	A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows: * Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors.; * Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if \<2 mm, score 1 - if 2-5 mm, and score 5 - if \>5 mm
change in pain score	Baseline,1 months, and 3 months	Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 ("0" is pain-free and "10" is severe intolerable pain).

Secondary Outcome Measures

Name	Time	Method
Duration of operation	Baseline	Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure.
Number of Needle Relocation	Baseline	The need to relocate the needle after first puncture of both needles will be used to compare between the efficacies of the computer guided arthrocentesis guide and the conventional free hand arthrocentesis.

Trial Locations

Locations (1)

Outpatient clinic of Oral and Maxillofacial Surgery; 🇪🇬 Alexandria, Egypt