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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

ConditionTMJ Disc Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ranges from 18 to 50 years.

Patients with adequate follow up duration for outcome assessment.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • dextrose 5%

    Other intervention

    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 intervention

    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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Group 1 patients with anterior disc displacement with reductionActive comparator 1 intervention
Group B: Group 2 patients with anterior disc displacement of reductionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Primary Outcome Measure: 1\. 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

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

Secondary outcomes

1

Change in Maximal Interincisal Opening (MIO) Measured in Millimeters

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).

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

Other outcomes

1

Presence or Absence of Joint Clicking (Binary Outcome)

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

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: