Temporomandibular Joint DisordersNCT04317560
Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders
A study testing Arthrocentesis and injectable platelet rich fibrin injection in people with Temporomandibular Joint Disorders, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial aims to evaluate the efficacy of liquid platelet-rich fibrin administration at different Wilkes stages. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Arthrocentesis and injectable platelet rich fibrin injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral internal temporomandibular disorder
- localized temporomandibular joint pain
- Scoring 3 and above in Wilke's classification.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Aydin
Burcu Gürsoytrak, 0505 5628541, dt_burcupoyraz@hotmail.com
About this study
Official title: Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders
This randomized clinical trial aims to evaluate the efficacy of liquid platelet-rich fibrin administration at different Wilkes stages.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Arthrocentesis, injectable platelet rich fibrin injection
- Keywords
- Liquid Platelet Rich Fibrin, Temporomandibular Joint Disorders, Wilkes classification
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrocentesisProcedure or surgery
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 injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthrocentesis | Active comparator | 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. Receives: Procedure: Arthrocentesis |
| Arthrocentesis plus i-PRF injection | Experimental | 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. Receives: Procedure: Arthrocentesis; Procedure: injectable platelet rich fibrin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: operation time, tenth day, end of first month, end of third month
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.
Measured: operation time, tenth day, end of first month, end of third month
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.
Measured: operation time, tenth day, end of first month, end of third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Mar 2019
- Primary completion28 Feb 2020
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Gürsoytrak, Aydin Adnan Menderes University
- Investigators
- Burcu GURSOYTRAK, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317560
- Sponsor's protocol ID
- 2018-049
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30231809Pihut 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.
PubMed 25157351Zardeneta 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.
PubMed 9216503Helkimo 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.
PubMed 4524733Nitzan 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.
PubMed 9024352
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT04317560
- Acronym / sponsor ID
- 2018-049
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Liquid Platelet Rich Fibrin, Temporomandibular Joint Disorders, Wilkes classification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrocentesis | Active comparator | Procedure: Arthrocentesis2 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 | Experimental | Procedure: Arthrocentesis, Procedure: injectable platelet rich fibrin injection2 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unilateral internal temporomandibular disorder
- localized temporomandibular joint pain
- Scoring 3 and above in Wilke's classification.
Key exclusion criteria (7 listed)
- Autoimmune diseases
- Significant mechanical obstruction that prevents mouth opening
- Acute capsulitis,
- Benign or malignant temporomandibular joint lesions
- Neurological disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrocentesis2 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. | Procedure or surgery | Arthrocentesis, Arthrocentesis plus i-PRF injection |
| injectable platelet rich fibrin injection2 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. | Procedure or surgery | Arthrocentesis plus i-PRF injection |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Background: PubMed 30231809Albilia 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.
- Background: PubMed 25157351Pihut 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.
- Background: PubMed 9216503Zardeneta 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.
- Background: PubMed 4524733Helkimo 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.
- Background: PubMed 9024352Nitzan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu GURSOYTRAK study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis and injectable platelet rich fibrin injection in people with Temporomandibular Joint Disorders, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burcu GURSOYTRAK (+902562133939, dt_burcupoyraz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helkimo Clinical Dysfunction Score improvement over time (time frame: operation time, tenth day, end of first month, end of third month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317560, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.