Clinical trial NCT06446843: Platelet-Rich Fibrin and Hyaluronic Acid vs. Hyaluronic Acid Injection for TMJ Internal Derangement
Official title: Assessment of Injectable Platelet-rich Fibrin With Hyaluronic Acid Versus Hyaluronic Acid in Management of Temporomandibular Joint Internal Derangement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internal Derangement
Keywords: Hyaluronic acid
Injectable PRF
TMJ Internal derangement
Temporomandibular joint
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#39;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

Eligibility criteria: 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.

Primary outcomes:
measure: pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening
timeFrame: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
measure: Maximum mouth opening
timeFrame: 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:
measure: MRI disc angle changes
timeFrame: preoperative examination (baseline) and 6 months after the procedure.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Associate professor at Faculty of Dentistry, Cairo University
name: Walaa Kadry
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.