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

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Arthrocentesis
injectable platelet rich fibrin injection
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Liquid Platelet Rich Fibrin, Temporomandibular Joint Disorders, Wilkes classification

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthrocentesis

Arthrocentesis plus i-PRF injection

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
March 19, 2020
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT04317560
Brief Title
Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders
Official Title
Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Liquid Platelet Rich Fibrin, Temporomandibular Joint Disorders, Wilkes classification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthrocentesis
Arm Type
Active Comparator
Arm 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.
Arm Title
Arthrocentesis plus i-PRF injection
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Arthrocentesis
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
injectable platelet rich fibrin injection
Intervention 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. 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 Measure Information:
Title
Helkimo Clinical Dysfunction Score improvement over time
Description
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.
Time Frame
operation time, tenth day, end of first month, end of third month
Title
Visual Analog Scale improvement over time
Description
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.
Time Frame
operation time, tenth day, end of first month, end of third month
Title
Maximum incisal opening improvement over time
Description
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.
Time Frame
operation time, tenth day, end of first month, end of third month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu GURSOYTRAK
Phone
+902562133939
Email
dt_burcupoyraz@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Uğur KARADAYI
Phone
+905555976270
Email
dtkaradayi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu GURSOYTRAK
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Study Director
Facility Information:
Facility Name
Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
City
Aydın
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burcu Gürsoytrak
Phone
0505 5628541
Email
dt_burcupoyraz@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30231809
Citation
Albilia J DMD, MSc, Herrera-Vizcaino C DDS, Weisleder H BSc, Choukroun J MD, Ghanaati S MD, DMD, PhD. Liquid platelet-rich fibrin injections as a treatment adjunct for painful temporomandibular joints: preliminary results. Cranio. 2020 Sep;38(5):292-304. doi: 10.1080/08869634.2018.1516183. Epub 2018 Sep 20.
Results Reference
background
PubMed Identifier
25157351
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.
Results Reference
background
PubMed Identifier
9216503
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. doi: 10.1016/s0278-2391(97)90583-8.
Results Reference
background
PubMed Identifier
4524733
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. No abstract available.
Results Reference
background
PubMed Identifier
9024352
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. doi: 10.1016/s0278-2391(97)90233-0.
Results Reference
background

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

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