Platelet Rich FibrinNCT07078006
Injectable Platelet Rich Fibrin Versus Platelet Rich Plasma Injection in Degenerative Temporomandibular Joint
A study testing Platelet Rich Fibrin and Platelet Rich Plasma in people with Platelet Rich Fibrin and Platelet Rich Plasma Injection, run by Nasser Institute For Research and Treatment at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Rich Fibrin, Platelet Rich Plasma Injection, Degenerative Temporomandibular Joint
- What is being tested?
- Platelet Rich Fibrin and Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2023to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old.
- Both sexes.
- Patients with unilateral or bilateral temporomandibular joint (TMJ) osteoarthritis according to magnetic resonance imaging (MRI) evaluation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Injectable Platelet Rich Fibrin Versus Platelet Rich Plasma Injection in Degenerative Temporomandibular Joint
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).
Read the detailed description
Degenerative joint disease (DJD), a frequently observed as osteoarthritic condition in clinical practice, manifests as a persistent and continuous transformation in joint configuration due to the deterioration and attrition of articular cartilage, accompanied by modifications in the subchondral bone and other soft tissue.
Treatment includes physical therapy, pulsed electrical stimulation, pharmacological, topical ointments, supplements, steroid injections, hyaluronic acid (HA) injections, and acupuncture.
Further studies have been carried out to better investigate the effectiveness of different techniques to perform arthrocentesis by using growth factors, autologous solutions, or alternative materials; the materials most used are platelet-rich plasma (PRP) and HA in arthrocentesis or by injection.
- Conditions
- Platelet Rich Fibrin, Platelet Rich Plasma Injection, Degenerative Temporomandibular Joint
- Being tested
- Platelet Rich Fibrin, Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich FibrinOther
Patients underwent arthrocentesis followed by a platelet-rich fibrin (PRF) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.
Platelet Rich PlasmaOther
Patients underwent arthrocentesis followed by a platelet-rich plasma (PRP) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-procedure
Secondary outcomes (1)
Assessment of tissue repair
Tissue repair in the form of initiating fibrin coating around the osteoarthritic joint by using Magnetic Resonance Imaging (MRI) was recorded.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start22 Feb 2023
- Primary completion22 Dec 2023
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Rich FibrinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Institute For Research and Treatment
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Omar Samir, Nasser Institute For Research and Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078006
- Sponsor's protocol ID
- 55653465
- Status last verified
- Jul 2025
- First submitted
- 31 Dec 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Injectable Platelet Rich Fibrin Versus Platelet Rich Plasma Injection in Degenerative Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT07078006
- Acronym / sponsor ID
- 55653465
- Conditions
- Platelet Rich Fibrin, Platelet Rich Plasma Injection, Degenerative Temporomandibular Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nasser Institute For Research and TreatmentOther government
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Degenerative joint disease (DJD), a frequently observed as osteoarthritic condition in clinical practice, manifests as a persistent and continuous transformation in joint configuration due to the deterioration and attrition of articular cartilage, accompanied by modifications in the subchondral bone and other soft tissue.
Treatment includes physical therapy, pulsed electrical stimulation, pharmacological, topical ointments, supplements, steroid injections, hyaluronic acid (HA) injections, and acupuncture.
Further studies have been carried out to better investigate the effectiveness of different techniques to perform arthrocentesis by using growth factors, autologous solutions, or alternative materials; the materials most used are platelet-rich plasma (PRP) and HA in arthrocentesis or by injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Platelet Rich FibrinPatients underwent arthrocentesis followed by a platelet-rich fibrin (PRF) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks. |
| Group II | Active comparator | Other: Platelet Rich PlasmaPatients underwent arthrocentesis followed by a platelet-rich plasma (PRP) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old.
- Both sexes.
- Patients with unilateral or bilateral temporomandibular joint (TMJ) osteoarthritis according to magnetic resonance imaging (MRI) evaluation.
Key exclusion criteria (7 listed)
- Patients under any type of antiplatelet or anticoagulant medications.
- Cardiovascular, renal, or hepatic disease.
- Diabetes.
- Anemia.
- Vascular insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich FibrinPatients underwent arthrocentesis followed by a platelet-rich fibrin (PRF) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks. | Other | Group I |
| Platelet Rich PlasmaPatients underwent arthrocentesis followed by a platelet-rich plasma (PRP) injection using a conventional temporomandibular joint (TMJ) injection technique, aided by facial anatomical landmarks. | Other | Group II |
Primary outcome
Pain improvement
Time frame: 6 months post-procedure
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.
1 secondary outcome
Assessment of tissue repair
Time frame: 6 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin and Platelet Rich Plasma in people with Platelet Rich Fibrin and Platelet Rich Plasma Injection, run by Nasser Institute For Research and Treatment at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain improvement (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.