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

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Procedure: Patients who received treatment involving ARS and arthrocentesis only; Procedure: Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection

• Registration Number: NCT06132802
• Lead Sponsor: Mahmoud Mohammed Mahmoud Nasef

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-10-02
• Primary Completion: 2022-10-14
• Study Completion: 2022-10-14
• Status Verified: 2023-11
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Last Update Submitted: 2023-11-10
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I: Patients who received treatment involving ARS and arthrocentesis only	Patients who received treatment involving ARS and arthrocentesis only	-
Group II: Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection	Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection	-

Primary Outcome Measures

Name	Time	Method
Maximum mouth opening	First week, first month, third months, and sixth months	Maximum Mouth Opening was determined by measuring the distance between the incisal edges of the upper and lower incisors. In Millimeter (mm)
Pain score	First week, first month, third months, and sixth months	Using Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Right and left lateral excursion	First week, first month, third months, and sixth months	In Millimeter (mm)

Trial Locations

Locations (1)

Faculty of Dental Medicine Al-Azhar University; 🇪🇬 Assuit, Egypt