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

NCT ID: NCT06205667

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-09-30

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.

Conditions

TMJ - Oral &Maxillofacial Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Computer Guided Arthrocentesis

a study group injected intra-articularly through TMJ using a computer-guided template.

Group Type: EXPERIMENTAL

Computer Guided Arthrocentesis

Intervention Type: PROCEDURE

patients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus.

Conventional Arthrocentesis

a control group which injected intra-articular through TMJ using conventional method based on anatomical landmark determination

Group Type: ACTIVE_COMPARATOR

Conventional Arthrocentesis

Intervention Type: PROCEDURE

patients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination

Interventions

Computer Guided Arthrocentesis

patients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus.

Intervention Type: PROCEDURE

Conventional Arthrocentesis

patients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ainshams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FD-ASU-RCC.IM022204

Identifier Type: -

Identifier Source: org_study_id