Evaluation of Anterior Repositioning Guided Splint Combined With or Without I Platelet-rich Fibrin

Temporomandibular Joint Disorders Clinical Trial

Official title:

Evaluation of Anterior Repositioning Guided Splint Combined With or Without Injectable Platelet-rich Fibrin in Treatment of TMJ Internal Derangement.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06132802
• Other study ID #: AUAREC20210100-07
• Status: Completed
• Phase: N/A
• Start date: October 2, 2021
• Est. completion date: October 14, 2022

Study information

• Verified date: November 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate clinically and radiographically the effectiveness of arthrocentesis and injection of I-PRF with wearing ARS in comparison to arthrocentesis and ARS only.

Description:

The patient will be seated at a 45° angle with the head turned toward the unaffected side. After preparing and disinfecting the target site with betadine, two points will be marked over the affected joint. Local anesthesia will be administered to block the auriculotemporal nerve. Using 19-gauge needles, the superior joint space will be distended with 2-3 ml of Ringer's solution. Another needle will be inserted into the distended compartment near the articular eminence to facilitate solution flow. Lactated Ringer's solution, connected to one needle, will be infused with sufficient pressure (200 mL in 15-20 minutes) to release adhesions. Following the removal of one needle, 2 ml of injectable platelet-rich fibrin (PRF) will be injected into the superior joint space.

For the preparation of injectable PRF, 20 ml of the patient's blood will be drawn and divided into two 10 ml vaccutainers. After centrifugation, the obtained PRF will be aspirated into a 5 ml syringe, and 1.5 to 2 ml of PRF will be injected into the superior joint space.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 years and older.

• History of unilateral or bilateral disc displacement without reduction (DDwoR) of the temporomandibular joint (TMJ) confirmed by MRI.

• Presence of TMJ pain and restricted maximum mouth opening.

• No improvement with conservative treatment.

• Absence of MRI contraindications.

Exclusion Criteria:

• Patients having any systemic disease that could interfere with the TMJ treatment or assessment.

• Patients having previous TMD treatment modalities or previous TMJ surgery.

• Patients with a previous history of oral and or maxillofacial trauma.

• Patients that are contraindicated to perform MRI.

• Completely or partially edentulous patients were also excluded.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Patients who received treatment involving ARS and arthrocentesis only
A 5mm acrylic anterior repositioning splint (ARS) with maxillary coverage was crafted from alginate impressions. After arthrocentesis, the ARS was worn incrementally over six months, starting at two hours and reaching 14 hours daily. In the second week, wear time was continuous, increasing to 24 hours daily (excluding meals) until the sixth month. The ramp was removed in the seventh week. Follow-ups involved grinding the splint by 1mm every four weeks. Arthrocentesis included anesthesia, betadine prep, and using two 18-gauge needles to inject Ringer's lactate solution (100-200 cc) for joint lavage, freeing the disc by moving the lower jaw in various orientations.
• Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection
A 5mm acrylic anterior repositioning splint (ARS) was crafted from alginate impressions, secured with Adam's clasps on upper first molars. After arthrocentesis, patients wore the splint incrementally over six months, starting at two hours and reaching 24 hours daily (excluding meals). The ramp was removed in the seventh week, and follow-ups included grinding the splint by 1mm every four weeks until it reached 3mm, guided by articulating paper. Arthrocentesis involved administering anesthesia, prepping the area with betadine, and using two 18-gauge needles to inject 2-3 ml of Ringer's lactate solution for joint lavage. The lower jaw was moved to free the disc and release fibrous tissue. I-PRF preparation included centrifuging collected blood for 3 minutes at 700 rpm, and the resulting I-PRF was injected into the superior joint space of the lavaged joints.

Locations

Country	Name	City	State
Egypt	Faculty of Dental Medicine Al-Azhar University	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Mahmoud Mohammed Mahmoud Nasef

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

AbdulRazzak NJ, Sadiq JA, Jiboon AT. Arthrocentesis versus glucocorticosteroid injection for internal derangement of temporomandibular joint. Oral Maxillofac Surg. 2021 Jun;25(2):191-197. doi: 10.1007/s10006-020-00901-3. Epub 2020 Sep 1. — View Citation

Herrera-Vizcaino C, Dohle E, Al-Maawi S, Booms P, Sader R, Kirkpatrick CJ, Choukroun J, Ghanaati S. Platelet-rich fibrin secretome induces three dimensional angiogenic activation in vitro. Eur Cell Mater. 2019 Apr 9;37:250-264. doi: 10.22203/eCM.v037a15. — View Citation

Marzook HAM, Abdel Razek AA, Yousef EA, Attia AAMM. Intra-articular injection of a mixture of hyaluronic acid and corticosteroid versus arthrocentesis in TMJ internal derangement. J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):30-34. doi: 10.1016/j.jormas.2019.05.003. Epub 2019 May 20. — View Citation

Teama UA. Evaluation of Injectable platelet rich fibrin for the management of Tempromandibular joint internal derangement.(clinical evaluation). Egy Dent J. 2020; 66:883-91.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum mouth opening	Maximum Mouth Opening was determined by measuring the distance between the incisal edges of the upper and lower incisors. In Millimeter (mm)	First week, first month, third months, and sixth months
Primary	Pain score	Using Visual Analogue Scale (VAS)	First week, first month, third months, and sixth months
Secondary	Right and left lateral excursion	In Millimeter (mm)	First week, first month, third months, and sixth months