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Efficacy of Injectable PRF in Management of TMJ Internal Derangement

NCT07789860 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-27

No results posted yet for this study

Summary

This study evaluated the efficacy of injectable platelet-rich fibrin both clinically and using MRI in management of temporomandibular joint internal derangement

Conditions

  • Temporomandibular Joint Internal Derangement

Interventions

PROCEDURE

TMJ arthrocentesis

Joint arthrocentesis was done to wash out any inflammatory exudate that were detected clinically as joint swelling or as white dots in T2 MRI images. The two needle arthrocentesis technique was used under local anesthesia. Two points were marked along the canthotragal line; the first /posterior point was marked 10mm along the line and 2mm below it ( representative of the glenoid fossa) whereas the second/ anterior point was marked 20mm along the line and 10mm below it( representative of the articular eminence). The first needle was inserted first and about 20ml of ringer's solution was injected to distend the joint capsule then the second needle was inserted and about 100ml of ringer's solution was injected. Throughout the whole procedure, the patients were asked to open, close and protrude their jaw and move their jaw laterally to help the fluid diffuse through the joint and release any adhesions.

BIOLOGICAL

Autologous platelet rich fibrin ( injectable PRF)

Single intraarticular administration of 2ml of injectable PRF immediately after TMJ arthrocentesis. Injectable PRF was prepared immediately before arthrocentesis from centrifuging (TD4 centrifuge, Hunan Lab we scientific instruments, China) of blood taking from the ulnar vein in a plain glass coated tube without anticoagulants at 700 rpm for 3 minutes , after centrifuging it was separated from the blood hemocytes as I-PRF was collected on the top of the tube while the blood hemocytes was precipitated in the bottom of the tube , 2ml of I-PRF was collected then injected directly into the joint after arthrocentesis with ringers solution through the first needle.

DEVICE

Hyaluronic acid gel (HA)

A single intraarticular administration of 2ml of low molecular weight Hyaluronic acid gel ( Hyalgan, hyaluronic acid sodium salt, Fidia pharmaceuticals, Italy) immediately after joint arthrocentesis.

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Mohamed A. El sholkamy, Professor of surgery · Department of oral and maxillofacial surgery, faculty of Dentistry Suez canal university ,Ismailia,Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-09-20
Completion
2024-10-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789860 on ClinicalTrials.gov