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

A

Aydin Adnan Menderes University

Status

Unknown

Conditions

Temporomandibular Joint Disorders

Treatments

Procedure: Arthrocentesis
Procedure: injectable platelet rich fibrin injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04317560
2018-049

Details and patient eligibility

About

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

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

36 participants in 2 patient groups

Arthrocentesis
Active Comparator group
Description:
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.
Treatment:
Procedure: Arthrocentesis
Arthrocentesis plus i-PRF injection
Experimental group
Description:
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.
Treatment:
Procedure: Arthrocentesis
Procedure: injectable platelet rich fibrin injection

Trial contacts and locations

1

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Central trial contact

Burcu GURSOYTRAK; Uğur KARADAYI

Data sourced from clinicaltrials.gov

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