NCT07266714

Brief Summary

The aim of the study will be to evaluate the clinical efficacy of using ultrasound guidance during intra-articular injection of hyaluronic acid in the management of patients with TMJ internal derangement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Anterior Disk Displacement TMJ

Keywords

Temporomandibular Joint, Disc displacement with reduction, Ultrasound, Hyaluronic acid.

Outcome Measures

Primary Outcomes (4)

  • Pain (Visual Analogue Scale)

    Pain intensity will be assessed by visual analog scale (VAS) score. Zero score for no pain and 10 score for worst pain experienced

    preoperative and postoerative after 1 week, 3 month and 6 month

  • Clicking sound

    Clicking sound will be assessed as to its presence = 1 or absence = 0.

    preoperative and postoerative after 1 week, 3 month and 6 month

  • Maximum inter-incisal opening (MIO)

    will be measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.

    preoperative and postoerative after 1 week, 3 month and 6 month

  • Range of lateral mandibular excursions

    will be masseured by Vernier caliper as the horizontal distance in millimeter from maxillary mid line to mandibular mid line with the patient first moving the mandible to one side than to the other at the maximum extend

    preoperative and postoerative after 1 week, 3 month and 6 month

Study Arms (2)

Ultrasound guided itra-articular injection of hyaluronic acid

EXPERIMENTAL
Device: Ultrasound guided injection with hyaluronic acid

Conventional intra-articular injection of hyaluronic acid

EXPERIMENTAL
Other: Conventional

Interventions

Ultrasound guided injection with hyaluronic acidDEVICE

Ultrtasound Guided injection of Hyaluronic Acid

Ultrasound guided itra-articular injection of hyaluronic acid
ConventionalOTHER

Conventional injection of hyaluronic Acid

Conventional intra-articular injection of hyaluronic acid

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients that will be diagnosed disc displacement confirmed clinically and by Magnetic Resonance Imaging (MRI).
  • Patient not responding to conservative therapy
  • Patients age must be (18 - 50).
  • Patients having painful joint, clicking sound, with or without limited mouth opening.
  • Patient's ability and desire to complete the treatment protocol and follow-up visits.

You may not qualify if:

  • Patient with an inflammatory or connective tissue disease
  • Patient with previous invasive TMJ surgical procedure.
  • Patient with Neurologic disorders
  • History of injection of any substance into the target TMJ during previous 6 months.
  • Patient with a history of bony adhesion.
  • Malignant disease in the head and neck region.
  • Patient with a psychological problem.
  • Patients having gross mechanical restrictions and condylar fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 14323, Egypt

Location

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Sally Elsayed Abdelsameaa, Assistant Professor

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Muhammad Adel Al-Hawari, Lecturer

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Ayman Ahmed Yaseen, Lecturer

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
B.D.S( Aljouf University, 2021. Sakaka, KSA) Master Dgree at Oral surgery department (2022) Affiliation: Mansoura University

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

September 1, 2024

Primary Completion

July 30, 2025

Study Completion

September 30, 2025

Last Updated

December 5, 2025

Record last verified: 2025-09

Locations

EG(1)