NCT06856811

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

February 24, 2025

Last Update Submit

March 2, 2025

Conditions

Outcome Measures

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

    three months follow up

Study Arms (1)

unilateral anterior disc displacement with reduction

EXPERIMENTAL
Procedure: tmj lavage with ringer lactate solution

Interventions

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

unilateral anterior disc displacement with reduction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral anterior disc displacement with reduction according to Helkimo's clinical dysfunction index including (Covert et al., 2021a).:
  • Impaired range of movement.
  • Impaired TMJ dysfunction.
  • Muscles pain.
  • TMJ pain.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana'a University

Sanaa, Yemen

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
condylar position changes in anterior disc displacement with reduction

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 4, 2025

Study Start

August 1, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

March 4, 2025

Record last verified: 2025-03

Locations