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Clinical Trials/NCT06132802
NCT06132802
Completed
N/A

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

Mahmoud Mohammed Mahmoud Nasef1 site in 1 country30 target enrollmentOctober 2, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Temporomandibular Joint Disorders
Sponsor
Mahmoud Mohammed Mahmoud Nasef
Enrollment
30
Locations
1
Primary Endpoint
Maximum mouth opening
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2021
End Date
October 14, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mahmoud Mohammed Mahmoud Nasef
Responsible Party
Sponsor Investigator
Principal Investigator

Mahmoud Mohammed Mahmoud Nasef

Demonstrator at the Department of oral and Maxillofacial Surgery

Al-Azhar University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Maximum mouth opening

Time Frame: 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

Time Frame: First week, first month, third months, and sixth months

Using Visual Analogue Scale (VAS)

Secondary Outcomes

  • Right and left lateral excursion(First week, first month, third months, and sixth months)

Study Sites (1)

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