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NCT Number: NCT07129681

a Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Tomporomandibular Joint

The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with

concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with

anterior disc displacement with reduction of TMJ who did not respond favorably to conservative

treatment and to compare and infer which among the two procedures is more satisfactory,

whether dextrose 5% injection or Arthrocentesis.

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Key information

Conditions

TMJ Disc Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The Aim of this study is to evaluate the efficacy of intra-articular Dextrose injection with

concentration 5% in superior joint space of TMJ in comparison to arthrocentesis in patients with

anterior disc displacement with reduction of TMJ who did not respond favorably to conservative

treatment and to compare and infer which among the two procedures is more satisfactory,

whether dextrose 5% injection or Arthrocentesis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

-Patients diagnosed with anterior disc displacement with reduction of TMJ with pain,limited mouth opening and

painful clicking who underwent conservative therapy with physiotherapy but failed to receive any relief after 3

months of conservative therapy.

  • Age ranges from 18 to 50 years.
  • Patients with adequate follow up duration for outcome assessment.

Exclusion criteria

  • Patients having pain or reduced mouth opening due to fracture of the condyle.
  • patients having any degenerative changes in the TMJ.
  • patients having other systemic diseases such as polyarthritis.
  • patients having any neurological disorders.
  • Pregnant and lactating women.

Treatment and study plan

dextrose 5%

Other

Dextrose, is an osmotic proliferant which acts by dehydrating the cells at the injection site which utlimately leads to release of cellular fragments that act as chemo attractants and start the inflammatory cascade leading todeposition of collagen

Arthrocentesis/Saline

Other

Arthrocentesis , a highly successful, simple and minimally invasive procedure is a safe and simple method for treatment of anterior disc displacement with reduction of TMJ both in short term and long term follow up period, where it is a procedure of removing damaged tissues &inflammatory mediators.it can be the treatment modality for the for control group

Primary outcomes

  1. Change in Pain Severity Measured by Numerical Rating Scale (NRS)

    Time frame: Measured at baseline, 3 days and 3 months after injection

    Primary Outcome Measure:

    • Change in Pain Severity Measured by Numerical Rating Scale (NRS)

    Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe

    pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be

    calculated and analyzed . Data Aggregation: Mean change in NRS score

Secondary outcomes

  1. Change in Maximal Interincisal Opening (MIO) Measured in Millimeters

    Time frame: Measured at baseline, 3 days and 3 months after injection

    Maximal interincisal opening (MIO) will be measured using a sterilllized metal scale or a digital caliper, with values recorded in millimeters (mm).

    The mean change in MIO from baseline will be reported . Data Aggregation: Mean change in MIO (mm) with standard

    deviation (SD).

Other outcomes

  1. Presence or Absence of Joint Clicking (Binary Outcome)

    Time frame: Measured at baseline, 3 days and 3 months after injection

    Joint clicking will be assessed as a binary outcome (Yes/No) based on clinical examination and patient-reported

    symptoms. The percentage of participants with joint clicking at each time point will be reported.

    Data Aggregation: Percentage of participants with joint clicking at each time point

Study contacts

Contact information is provided by the study sponsor or research team.

Sandy Maged Ibrahim, bachelor's degree

CONTACT

[email protected]

+201149119389

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Temporomandibular Joint.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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