Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders

Not Applicable

• Conditions: Temporomandibular Joint Disorders
• Interventions: Procedure: Arthrocentesis; Procedure: injectable platelet rich fibrin injection

• Registration Number: NCT04317560
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

This randomized clinical trial aims to evaluate the efficacy of liquid platelet-rich fibrin administration at different Wilkes stages.

Detailed Description

Thirty six patients with unilateral painful internal derangement (ID) (Wilkes' 3-4-5) were included. Patients were divided into 2 groups. In group 1 were treated with only artrosythesis. In group 2 were treated with artrosythesis and liquid platelet rich fibrin. In group 2, patients were injected with 1.5-2cc of liquid platelet-rich fibrin within the superior joint space at operation day. Pain and subjective dysfunction were recorded using a visual analog scale and Helkimo index at operation day and tenth day, one month later and 3 months later.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2020-02-28
• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Study First Posted: 2020-03-23
• Last Update Posted: 2020-03-23
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Unilateral internal temporomandibular disorder
• localized temporomandibular joint pain
• Scoring 3 and above in Wilke's classification.

Exclusion Criteria

• Autoimmune diseases
• Significant mechanical obstruction that prevents mouth opening
• Acute capsulitis,
• Benign or malignant temporomandibular joint lesions
• Neurological disorders,
• Blood diseases and coagulation disorders
• Patients with a history of allergies or anaphylactic shock.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthrocentesis plus i-PRF injection	Arthrocentesis	2 tubes of blood were collected from the patients with the help of vacuumed 10 mL special liquid PRF tubes (Choukroun I-PRF Collection Tubes, Dr. Choukroun) after arthrocentesis. Blood tubes were centrifuged at 700rpm for 3 minutes. 3 mL of liquid PRF was obtained at the top of each tube. Only the second needle was removed without removing the first needle inserted. I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.
Arthrocentesis	Arthrocentesis	2 guiding points have been created on the skin. The first one is 10 mm in front of the tragus and 2 mm below the tragus line. The second guide point is on the same line, 20 mm in front of the tragus and 6 mm below. After the auriculotemporal nerve block was made, the first 20 gauge needle was inserted from the first point. 2mL Ringer's Lactate solution is injected into the temporomandibular joint area, and then a second 20 gauge needle is entered from the second guide point determined before and pressurized washing is performed with 100 mL of 5% lactate solution to enter the first needle and exit from the second needle.
Arthrocentesis plus i-PRF injection	injectable platelet rich fibrin injection	2 tubes of blood were collected from the patients with the help of vacuumed 10 mL special liquid PRF tubes (Choukroun I-PRF Collection Tubes, Dr. Choukroun) after arthrocentesis. Blood tubes were centrifuged at 700rpm for 3 minutes. 3 mL of liquid PRF was obtained at the top of each tube. Only the second needle was removed without removing the first needle inserted. I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale improvement over time	operation time, tenth day, end of first month, end of third month	The patient gives his pain a value between 0-10. The patients' pain scores were recorded by using a 10 cm visual analog scale (VAS) from 0, which represents no pain, to 10, which represents the worst possible pain.; Since lower scores represent better health, the amount of improvement between sessionsis calculated by subtracting the next score from the previous score.
Maximum incisal opening improvement over time	operation time, tenth day, end of first month, end of third month	It is the vertical distance between the incisal teeth when the patient opens his mouth to the maximum. It is measured with the help of a caliper.; Since higher scores represent better health, the amount of improvement between sessionsis calculated by subtracting the previous score from the next score.
Helkimo Clinical Dysfunction Score improvement over time	operation time, tenth day, end of first month, end of third month	In the Helkimo Clinical Dysfunction Index, the maximum mandibular movement limits are measured vertically and laterally. In addition, TMJ function, muscle pain, TMJ region pain and mandibular motion pain are evaluated separately. After all these evaluations, all the scores given are summed up and a total dysfunction score is obtained. If this total score is 0, the dysfunction is completely healed. If the total score is between 1 and 4, mild dysfunction, between 5 and 9, moderate dysfunction, and between 10 and 25 severe dysfunction.; Since lower scores represent better health, the amount of improvement between sessionsis calculated by subtracting the next score from the previous score.

Trial Locations

Locations (1)

Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery; 🇹🇷 Aydın, Turkey