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

NCT06446843 | Completed

• 1 other identifier: Ethical approval no.: 12 4 24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Internal Derangement

Keywords

Hyaluronic acid; Injectable PRF; TMJ Internal derangement; Temporomandibular joint

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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 (1)

• MRI disc angle changes

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

Study Arms (3)

(control group)

ACTIVE COMPARATOR

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

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

(study group1)

EXPERIMENTAL

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

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

(study group2)

EXPERIMENTAL

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

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

Interventions

(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

(control group); (study group1); (study group2)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 02, Egypt

Location

Related Publications (6)

• Yuce E, Komerik N. Comparison of the Efficiacy of Intra-Articular Injection of Liquid Platelet-Rich Fibrin and Hyaluronic Acid After in Conjunction With Arthrocentesis for the Treatment of Internal Temporomandibular Joint Derangements. J Craniofac Surg. 2020 Oct;31(7):1870-1874. doi: 10.1097/SCS.0000000000006545.

  PMID: 32433129 BACKGROUND

• Ghoneim NI, Mansour NA, Elmaghraby SA, Abdelsameaa SE. Treatment of temporomandibular joint disc displacement using arthrocentesis combined with injectable platelet rich fibrin versus arthrocentesis alone. J Dent Sci. 2022 Jan;17(1):468-475. doi: 10.1016/j.jds.2021.07.027. Epub 2021 Aug 21.

  PMID: 35028072 BACKGROUND

• Harba AN, Harfoush M. Evaluation of the participation of hyaluronic acid with platelet-rich plasma in the treatment of temporomandibular joint disorders. Dent Med Probl. 2021 Jan-Mar;58(1):81-88. doi: 10.17219/dmp/127446.

  PMID: 33847473 BACKGROUND

• Hegab AF, Hameed HIAA, Hassaneen AM, Hyder A. Synergistic effect of platelet rich plasma with hyaluronic acid injection following arthrocentesis to reduce pain and improve function in TMJ osteoarthritis. J Stomatol Oral Maxillofac Surg. 2023 Feb;124(1S):101340. doi: 10.1016/j.jormas.2022.11.016. Epub 2022 Nov 19.

  PMID: 36414172 BACKGROUND

• Isik G, Kenc S, Ozveri Koyuncu B, Gunbay S, Gunbay T. Does the Use of Injectable Platelet-Rich Fibrin After Arthrocentesis for Disc Displacement Without Reduction Improve Clinical Outcomes? J Oral Maxillofac Surg. 2023 Jun;81(6):689-697. doi: 10.1016/j.joms.2023.02.014. Epub 2023 Mar 13.

  PMID: 36924792 BACKGROUND

• Toameh MH, Alkhouri I, Karman MA. Management of patients with disk displacement without reduction of the temporomandibular joint by arthrocentesis alone, plus hyaluronic acid or plus platelet-rich plasma. Dent Med Probl. 2019 Jul-Sep;56(3):265-272. doi: 10.17219/dmp/109329.

  PMID: 31577070 BACKGROUND

Study Officials

• Walaa Kadry

  Associate professor at Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal researcher at oral and Maxillofacial surgery department

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 6, 2024
• Study Start: September 18, 2024
• Primary Completion: March 25, 2025
• Study Completion: April 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

EG (1)