Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study

Not Applicable

Completed

• Conditions: TMJ - Oral &Maxillofacial Surgery
• Interventions: Procedure: Conventional Arthrocentesis; Procedure: Computer Guided Arthrocentesis

• Registration Number: NCT06205667
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-06-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-09-30
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds.
• Patients who did not responded to conservative treatment for a minimum of 3 months.
• Obtaining written informed consents signed by the patients.

Exclusion Criteria

• Patients suffering from any muscular disorders as myofascial pain or myofascial pain with limitations
• If the disc was not visible in the MRI examination.
• Patients who previously received intra-articular injection of any medication or exposed to any other TMJ invasive procedure.
• Patients who suffer from any connective tissue diseases as rheumatoid arthritis or neurologic disorders.
• Patients with history of major jaw trauma, bisphosphonate-derived drug use, pregnancy, alcohol or drug dependence.
• Patients with gross mechanical restrictions or history of adhesion (fibrous or bony).
• Patients with psychiatric disease or substance abuse or have an allergy to the substance used in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Arthrocentesis	Conventional Arthrocentesis	a control group which injected intra-articular through TMJ using conventional method based on anatomical landmark determination
Computer Guided Arthrocentesis	Computer Guided Arthrocentesis	a study group injected intra-articularly through TMJ using a computer-guided template.

Primary Outcome Measures

Name	Time	Method
Operation time started from first needle insertion.	intaoperative
Attempts number of needle puncture	intraoperative

Secondary Outcome Measures

Name	Time	Method
Maximum mouth opening	1week, 1, 3 and 6	Change of mouth opening measurement using RDC/TMD
Pain reduction	1week, 1, 3 and 6	Pain assessment using Visual analogue Scale

Trial Locations

Locations (1)

Ainshams university; 🇪🇬 Cairo, Egypt