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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-04-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Arthrocentesis

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Arthrocentesis

Intervention Type PROCEDURE

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.

injectable platelet rich fibrin injection

Intervention Type PROCEDURE

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. I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.

Interventions

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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.

Intervention Type PROCEDURE

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. I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No