Condylar Position Changes in Anterior Disc Displacement with Reduction

the goal of this clinical trial is to know if TMJ lavage does change the condyle position in patients diagnosed with unilateral anterior disc displacement with reduction. The main questions it aims to answer are:

• Is the condyle position in anterior disc displacement with reduction joints are the same in normal joints?
• Does TMJ lavage will affect the condyle position, or affects the contralateral condyle position? Researchers will compare condyle position in unilateral anterior disc displacement with reduction to the normal joint using CBCT before and after lavage to see if any changes in position will occur in even side.

Participants will:

Make CBCT for both condyles before lavage and after three months post lavage. Visit clinic after two weeks, one month, and three months to evaluate the clinical data.

Study Overview

• Status: Completed
• Conditions: TMJ Disorder
• Intervention / Treatment: Procedure: tmj lavage with ringer lactate solution

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Yemen
  • Sana'a, Yemen
    • Sana'a University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Unilateral anterior disc displacement with reduction according to Helkimo's clinical dysfunction index including (Covert et al., 2021a).:

  1. Impaired range of movement.
  2. Impaired TMJ dysfunction.
  3. Muscles pain.
  4. TMJ pain.

Exclusion Criteria:

• • Bilateral anterior disc displacement with reduction.

  • Previous fracture in TMJ.
  • Any pathological lesion in TMJ.
  • Congenital craniofacial anomalies.
  • Any previous surgical procedure in TMJ.
  • Any medically compromised patient (mental deficiency, osteoporosis…)
  • Previous arthrocentesis in TMJ.
  • Partial or complete edentulous patients.
  • Any psychological patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: unilateral anterior disc displacement with reduction	Procedure: tmj lavage with ringer lactate solution; tmj lavage using 150ml ringer lactate in symptomatic side of unilateral anterior disc displacement with reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measuring joint spaces in coronal, sagittal and axial views in mm as follows: sagittal view: measuring superior, posterior and anterior space, coronal measuring medial and lateral joint spaces, axial measuring the intercondylar distance and angle	three months follow up

Collaborators and Investigators

• Sponsor: Sana'a University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders
• Other Study ID Numbers: tmj lavage

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No