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

Cairo University (CU)

Status: Completed

Conditions: Internal Derangement

Treatments: Combination Product: (Arthrocentesis followed by i-PRF +HA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06446843

Ethical approval no.: 12 4 24

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

(control group)

Active Comparator group

Description:

arthrocentesis with Ringer's lactate solution, of the superior joint compartment

Treatment:

Combination Product: (Arthrocentesis followed by i-PRF +HA)

(study group1)

Experimental group

Description:

arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1ml of HA.

Treatment:

Combination Product: (Arthrocentesis followed by i-PRF +HA)

(study group2)

Experimental group

Description:

arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1 ml of i- PRF then1ml of HA following arthrocentesis.

Treatment:

Combination Product: (Arthrocentesis followed by i-PRF +HA)