NCT07078006

Brief Summary

The study aimed to compare the efficacy of injectable platelet rich fibrin (I-PRF) versus platelet rich plasma (PRP) injection in degenerative temporomandibular joint (TMJ).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 22, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

December 31, 2024

Last Update Submit

July 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain improvement

    Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS was recorded preoperatively, immediately after the procedures, 1 month, 3 months, and 6 months postoperatively.

    6 months post-procedure

Secondary Outcomes (1)

  • Assessment of tissue repair

    6 months post-procedure

Study Arms (2)

Group I

EXPERIMENTAL

Patients underwent arthrocentesis followed by a platelet-rich fibrin (PRF) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.

Other: Platelet Rich Fibrin

Group II

ACTIVE COMPARATOR

Patients underwent arthrocentesis followed by a platelet-rich plasma (PRP) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.

Other: Platelet Rich Plasma

Interventions

Patients underwent arthrocentesis followed by a platelet-rich fibrin (PRF) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.

Group I

Patients underwent arthrocentesis followed by a platelet-rich plasma (PRP) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.

Group II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old.
  • Both sexes.
  • Patients with unilateral or bilateral temporomandibular joint (TMJ) osteoarthritis according to magnetic resonance imaging (MRI) evaluation.

You may not qualify if:

  • Patients under any type of antiplatelet or anticoagulant medications.
  • Cardiovascular, renal, or hepatic disease.
  • Diabetes.
  • Anemia.
  • Vascular insufficiency.
  • Peripheral neuropathy.
  • Previous surgery for TMJ and rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nasser

Cairo, 112345, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oral and Maxillofacial Surgery Department, Faculty of Oral & Dental Medicine, AL Azhar University, Assuit, Egypt.

Study Record Dates

First Submitted

December 31, 2024

First Posted

July 22, 2025

Study Start

February 22, 2023

Primary Completion

December 22, 2023

Study Completion

July 23, 2024

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations