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

Cairo University36 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Internal Derangement

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

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.

Maximum mouth opening

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

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.

Secondary Outcomes

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.

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