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

January 4, 2024 updated by: Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ainshams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Attempts number of needle puncture
Time Frame: intraoperative
intraoperative
Operation time started from first needle insertion.
Time Frame: intaoperative
intaoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening
Time Frame: 1week, 1, 3 and 6
Change of mouth opening measurement using RDC/TMD
1week, 1, 3 and 6
Pain reduction
Time Frame: 1week, 1, 3 and 6
Pain assessment using Visual analogue Scale
1week, 1, 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Estimated)

January 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • FD-ASU-RCC.IM022204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on TMJ - Oral &Maxillofacial Surgery

Clinical Trials on Computer Guided Arthrocentesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe