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

NCT06205667 | Completed

• 1 other identifier: FD-ASU-RCC.IM022204
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Attempts number of needle puncture

  intraoperative

• Operation time started from first needle insertion.

  intaoperative

Secondary Outcomes (2)

• Maximum mouth opening

  1week, 1, 3 and 6

• Pain reduction

  1week, 1, 3 and 6

Study Arms (2)

Computer Guided Arthrocentesis

EXPERIMENTAL

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

Procedure: Computer Guided Arthrocentesis

Conventional Arthrocentesis

ACTIVE COMPARATOR

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

Procedure: Conventional Arthrocentesis

Interventions

Computer Guided Arthrocentesis 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.

Computer Guided Arthrocentesis

Conventional Arthrocentesis PROCEDURE

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

Conventional Arthrocentesis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams university

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: June 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: September 30, 2023
• Last Updated: January 16, 2024

Record last verified: 2021-03

Locations

EG (1)