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

Not Applicable

Completed

• Conditions: Internal Derangement
• Interventions: Combination Product: (Arthrocentesis following i-PRF +HA)

• Registration Number: NCT06446843
• Lead Sponsor: Cairo University

Brief 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. 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.

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

Study Timeline

• Study First Submitted: 2024-06-02
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-06
• Study Start: 2024-09-18
• Primary Completion: 2025-03-25
• Status Verified: 2025-04
• Study Completion: 2025-04-01
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(control group) will receive Arthrocentesis alone	(Arthrocentesis following i-PRF +HA)	arthrocentesis with Ringer's lactate solution, of the superior joint compartment
(study group2)(Arthrocentesis following i-PRF +HA)	(Arthrocentesis following i-PRF +HA)	arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1 ml of i- PRF then1ml of HA following arthrocentesis.
(study group1) will receive (Arthrocentesis+HA)	(Arthrocentesis following i-PRF +HA)	arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1ml of HA following arthrocentesis.

Primary Outcome Measures

Name	Time	Method
pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening	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)
Maximum mouth opening	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 Outcome Measures

Name	Time	Method
MRI disc angle changes	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.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt