- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04317560
Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders
Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burcu GURSOYTRAK
- Phone Number: +902562133939
- Email: dt_burcupoyraz@hotmail.com
Study Contact Backup
- Name: Uğur KARADAYI
- Phone Number: +905555976270
- Email: dtkaradayi@gmail.com
Study Locations
-
-
-
Aydın, Turkey
- Recruiting
- Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
-
Contact:
- Burcu Gürsoytrak
- Phone Number: 0505 5628541
- Email: dt_burcupoyraz@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Experimental: 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.
|
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.
I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Helkimo Clinical Dysfunction Score improvement over time
Time Frame: 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. |
operation time, tenth day, end of first month, end of third month
|
Visual Analog Scale improvement over time
Time Frame: 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. |
operation time, tenth day, end of first month, end of third month
|
Maximum incisal opening improvement over time
Time Frame: 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. |
operation time, tenth day, end of first month, end of third month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Burcu GURSOYTRAK, Aydin Adnan Menderes University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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