Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint

October 30, 2024 updated by: Hams Hamed Abdelrahman

Evaluation of Computer-guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint (a Randomized Controlled Clinical Trial)

Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point.

Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
      • Alexandria, Egypt, 00302
        • Outpatient clinic of Oral and Maxillofacial Surgery

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Patients diagnosed with internal derangement according to Wilkins stage I and II.
  • Patients who would not respond to conservative treatment as a first line of treatment.

Exclusion Criteria:

  • Patients with Wilkins stage III, IV, V.
  • History of mandibular fracture.
  • Lactating, pregnant or planning pregnancy women.
  • Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: conventional sodiumhyaluronate injections
Patients will be treated with conventional sodium hyaluronate injections in superior TMJ space
Experimental: Study Group
Other: Computer guided sodium hyaluronate injections
Patients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TMJ dysfunction
Time Frame: Baseline, 1 month, and 3 months

A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows:

  • Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors.
  • Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if <2 mm, score 1 - if 2-5 mm, and score 5 - if >5 mm
Baseline, 1 month, and 3 months
change in pain score
Time Frame: Baseline,1 months, and 3 months
Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 ("0" is pain-free and "10" is severe intolerable pain).
Baseline,1 months, and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of operation
Time Frame: Baseline
Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure.
Baseline
Number of Needle Relocation
Time Frame: Baseline
The need to relocate the needle after first puncture of both needles will be used to compare between the efficacies of the computer guided arthrocentesis guide and the conventional free hand arthrocentesis.
Baseline

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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)

May 3, 2024

Primary Completion (Actual)

August 21, 2024

Study Completion (Actual)

October 24, 2024

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0870-04

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.

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