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Completed

NCT Number: NCT06446843

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

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Key information

Conditions

Internal Derangement

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 02, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

(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

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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