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CompletedNCT06856811Updated Mar 4, 2025

Condylar Position Changes in Anterior Disc Displacement with Reduction

An interventional study of tmj lavage with ringer lactate solution in TMJ Disorder, sponsored by Sana'a University. Completed at 1 site in Yemen. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Sana'a University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Sex
All
01

Study summary

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.

02

Conditions studied

  • TMJ Disorder
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    unilateral anterior disc displacement with reduction

    Procedure: tmj lavage with ringer lactate solution

Interventions

  • Proceduretmj lavage with ringer lactate solution

    tmj lavage using 150ml ringer lactate in symptomatic side of unilateral anterior disc displacement with reduction

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: three months follow up

06

Study locations

1 site
  • Sana'a University
    Sana'a, Yemen
07

Registry details

Key details

Study ID
NCT06856811
Lead sponsor
Sana'a University
Responsible party
Suha Hussein Mohammed Almoqayad (condylar position changes in anterior disc displacement with reduction, Sana'a University) — Principal investigator
First posted
Mar 4, 2025
Start date
Aug 1, 2023
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024
Last update
Mar 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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