AzTrials
AzTrials

Internal DerangementNCT06446843

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

A study testing (Arthrocentesis followed by i-PRF +HA) in people with Internal Derangement, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Internal Derangement
What is being tested?
(Arthrocentesis followed by i-PRF +HA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteEgypt
Study dates
18 Sep 2024to 1 Apr 2025
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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dentistry

    Cairo, 02

Other trials in Egypt

About this study

Official title: 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.

Read the 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

Being tested
(Arthrocentesis followed by i-PRF +HA)
Keywords
Hyaluronic acid, Injectable PRF, TMJ Internal derangement, Temporomandibular joint

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (Arthrocentesis followed by i-PRF +HA)Combination product

    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

Study groups in NCT06446843
Study groupRoleWhat they receive
(control group)Active comparatorarthrocentesis with Ringer's lactate solution, of the superior joint compartment
Receives: Combination Product: (Arthrocentesis followed by i-PRF +HA)
(study group1)Experimentalarthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1ml of HA.
Receives: Combination Product: (Arthrocentesis followed by i-PRF +HA)
(study group2)Experimentalarthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1 ml of i- PRF then1ml of HA following arthrocentesis.
Receives: Combination Product: (Arthrocentesis followed by i-PRF +HA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening

    Pain measured through a (10 scale) visual analogue scale (VAS)

    Measured: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.

  2. Maximum mouth opening

    mandibular mouth opening defined as MIO (maximum interincisal opening) >/35

    Measured: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.

Secondary outcomes (1)

  1. MRI disc angle changes

    MRI unit :degree of angle between the posterior margin of the disc and the vertical line drawn through the Centre of the condyle.

    Measured: preoperative examination (baseline) and 6 months after the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start18 Sep 2024
  3. Primary completion25 Mar 2025
  4. Study completion1 Apr 2025

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446843
Sponsor's protocol ID
Ethical approval no.: 12 4 24
Status last verified
Apr 2025
First submitted
2 Jun 2024
Last updated
9 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yuce E, Komerik N. Comparison of the Efficiacy of Intra-Articular Injection of Liquid Platelet-Rich Fibrin and Hyaluronic Acid After in Conjunction With Arthrocentesis for the Treatment of Internal Temporomandibular Joint Derangements. J Craniofac Surg. 2020 Oct;31(7):1870-1874. doi: 10.1097/SCS.0000000000006545.

    PubMed 32433129

  • Ghoneim NI, Mansour NA, Elmaghraby SA, Abdelsameaa SE. Treatment of temporomandibular joint disc displacement using arthrocentesis combined with injectable platelet rich fibrin versus arthrocentesis alone. J Dent Sci. 2022 Jan;17(1):468-475. doi: 10.1016/j.jds.2021.07.027. Epub 2021 Aug 21.

    PubMed 35028072

  • Harba AN, Harfoush M. Evaluation of the participation of hyaluronic acid with platelet-rich plasma in the treatment of temporomandibular joint disorders. Dent Med Probl. 2021 Jan-Mar;58(1):81-88. doi: 10.17219/dmp/127446.

    PubMed 33847473

  • Hegab AF, Hameed HIAA, Hassaneen AM, Hyder A. Synergistic effect of platelet rich plasma with hyaluronic acid injection following arthrocentesis to reduce pain and improve function in TMJ osteoarthritis. J Stomatol Oral Maxillofac Surg. 2023 Feb;124(1S):101340. doi: 10.1016/j.jormas.2022.11.016. Epub 2022 Nov 19.

    PubMed 36414172

  • Isik G, Kenc S, Ozveri Koyuncu B, Gunbay S, Gunbay T. Does the Use of Injectable Platelet-Rich Fibrin After Arthrocentesis for Disc Displacement Without Reduction Improve Clinical Outcomes? J Oral Maxillofac Surg. 2023 Jun;81(6):689-697. doi: 10.1016/j.joms.2023.02.014. Epub 2023 Mar 13.

    PubMed 36924792

  • Toameh MH, Alkhouri I, Karman MA. Management of patients with disk displacement without reduction of the temporomandibular joint by arthrocentesis alone, plus hyaluronic acid or plus platelet-rich plasma. Dent Med Probl. 2019 Jul-Sep;56(3):265-272. doi: 10.17219/dmp/109329.

    PubMed 31577070

Questions about this trial

What is this clinical trial studying?

A study testing (Arthrocentesis followed by i-PRF +HA) in people with Internal Derangement, run by Cairo University 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 7 inclusion and 9 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 9 Apr 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 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06446843, which also lists 6 linked publications.

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 9 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in