Platelet-Rich Fibrin and Hyaluronic Acid vs. Hyaluronic Acid Injection for TMJ Internal Derangement ((RCT))

April 5, 2025 updated by: Baghdad Mohammed abdo-alhage, Cairo University

Assessment of Injectable Platelet-rich Fibrin With Hyaluronic Acid Versus Hyaluronic Acid in Management of Temporomandibular Joint Internal Derangement

Injectable PRF technology, according to literature evidence, ensures the release of growth factors over time which play a major role in the release of regenerative factors for tissue repair after injection, while HA is an anti-inflammatory medication that can provide rapid relief from pain and inflammation in joints. It is a major natural component of synovial fluid that plays an important role in lubrication of synovial tissues However, its effect is typically temporary, and it doesn't promote tissue healing or regeneration.

For this reason, this protocol has been designed with the aim to investigate whether injection in the injection i- pRF with HA can achieve the same improvements of pain and function, compare this technique with arthrocentesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One group will receive arthrocentesis only, the second group will receive 1 mm hyaluronic acid injection and the third group will receive a mixture of 1 ml hyaluronic acid, 1 ml of injectable PRF

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Faculty of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Presence of TMJ-ID related symptoms.
  • Patients suffering from TMJ internal derangement (disc displacement with reduction).
  • Age limit between 20 and 45years so Patient less than 21years will need assent form …as well as written informed consent from the parents \guardians.
  • No previous TMJ surgical procedures
  • Acquisition of informed consent.
  • Cooperative patient
  • Patients free from any systemic disease that may affect the procedure.

Exclusion Criteria:

  • Previous malignant head and neck neoplasms.
  • Patients suffering from inflammatory or connective tissue systemic diseases.
  • Neurologic disorders.
  • History of bony or fibrous adhesion
  • Gross mechanical restrictions and condylar fractures, previous TMJ surgery, TMJ ankylosis, or acute infection.
  • Patients maintained on anti-coagulants, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks was also excluded in this study.
  • Uncooperative patient
  • Pregnant and lactating female.
  • Patients with systemic diseases (e.g., rheumatoid arthritis, psoriatic arthritis, or juvenile arthritis), and those who had shown symptoms of hypersensitivity to the HA solution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (control group)
arthrocentesis with Ringer's lactate solution, of the superior joint compartment
Combination product: (Arthrocentesis followed by i-PRF +HA)
Intra-articular I-PRF with HA will be injected in the joint,1 ml of I-PRF will be injected inside the joint, Then from 25mg/ml of HA , 1ml will be injected into the superior joint space
Experimental: (study group1)
arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1ml of HA.
Combination product: (Arthrocentesis followed by i-PRF +HA)
Intra-articular I-PRF with HA will be injected in the joint,1 ml of I-PRF will be injected inside the joint, Then from 25mg/ml of HA , 1ml will be injected into the superior joint space
Experimental: (study group2)

arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject

1 ml of i- PRF then1ml of HA following arthrocentesis.
Combination product: (Arthrocentesis followed by i-PRF +HA)
Intra-articular I-PRF with HA will be injected in the joint,1 ml of I-PRF will be injected inside the joint, Then from 25mg/ml of HA , 1ml will be injected into the superior joint space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening
Time Frame: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
mandibular mouth opening defined as MIO (maximum interincisal opening) >/35
evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening
Time Frame: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
Pain measured through a (10 scale) visual analogue scale (VAS)
evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI disc angle changes
Time Frame: preoperative examination (baseline) and 6 months after the procedure.
MRI unit :degree of angle between the posterior margin of the disc and the vertical line drawn through the Centre of the condyle.
preoperative examination (baseline) and 6 months after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Walaa Kadry, Associate professor at Faculty of Dentistry, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2024

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ethical approval no.: 12 4 24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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