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

Temporomandibular Joint Disorders Clinical Trial

Official title:

Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317560
• Other study ID #: 2018-049
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: March 2020
• Source: Aydin Adnan Menderes University
• Contact: Burcu GURSOYTRAK
• Phone: +902562133939
• Email: dt_burcupoyraz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 1, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Albilia JB DMD, MSc, Herrera-Vizcaino C DDS, Weisleder H BSc, Choukroun J DM, Ghanaati S MD, DMD, PhD. Liquid platelet-rich fibrin injections as a treatment adjunct for painful temporomandibular joints: preliminary results. Cranio. 2018 Sep 20:1-13. doi: 10.1080/08869634.2018.1516183. [Epub ahead of print] — View Citation

Helkimo M. Studies on function and dysfunction of the masticatory system. II. Index for anamnestic and clinical dysfunction and occlusal state. Sven Tandlak Tidskr. 1974 Mar;67(2):101-21. — View Citation

Nitzan DW, Samson B, Better H. Long-term outcome of arthrocentesis for sudden-onset, persistent, severe closed lock of the temporomandibular joint. J Oral Maxillofac Surg. 1997 Feb;55(2):151-7; discussion 157-8. — View Citation

Pihut M, Szuta M, Ferendiuk E, Zenczak-Wieckiewicz D. Evaluation of pain regression in patients with temporomandibular dysfunction treated by intra-articular platelet-rich plasma injections: a preliminary report. Biomed Res Int. 2014;2014:132369. doi: 10.1155/2014/132369. Epub 2014 Aug 3. — View Citation

Zardeneta G, Milam SB, Schmitz JP. Elution of proteins by continuous temporomandibular joint arthrocentesis. J Oral Maxillofac Surg. 1997 Jul;55(7):709-16; discussion 716-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helkimo Clinical Dysfunction Score improvement over time	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.	operation time, tenth day, end of first month, end of third month
Primary	Visual Analog Scale improvement over time	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.	operation time, tenth day, end of first month, end of third month
Primary	Maximum incisal opening improvement over time	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.	operation time, tenth day, end of first month, end of third month