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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-18

Study Completion Date

2025-04-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Internal Derangement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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(control group)

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

Group Type ACTIVE_COMPARATOR

(Arthrocentesis followed by i-PRF +HA)

Intervention Type 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 group1)

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

Group Type EXPERIMENTAL

(Arthrocentesis followed by i-PRF +HA)

Intervention Type 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 group2)

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

1 ml of i- PRF then1ml of HA following arthrocentesis.

Group Type EXPERIMENTAL

(Arthrocentesis followed by i-PRF +HA)

Intervention Type 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

Interventions

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(Arthrocentesis followed by i-PRF +HA)

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes