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

A

Ain Shams University

Status

Completed

Conditions

TMJ - Oral &Maxillofacial Surgery

Treatments

Procedure: Computer Guided Arthrocentesis
Procedure: Conventional Arthrocentesis

Study type

Interventional

Funder types

Other

Identifiers

NCT06205667
FD-ASU-RCC.IM022204

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

22 participants in 2 patient groups

Computer Guided Arthrocentesis
Experimental group
Description:
a study group injected intra-articularly through TMJ using a computer-guided template.
Treatment:
Procedure: Computer Guided Arthrocentesis
Conventional Arthrocentesis
Active Comparator group
Description:
a control group which injected intra-articular through TMJ using conventional method based on anatomical landmark determination
Treatment:
Procedure: Conventional Arthrocentesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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