Surgical ComplicationNCT05336578
Anti-inflammatory Effect of Platelet-Rıch Fıbrın
A study testing Platelet rich fibrin application in people with Surgical Complication and Pain, Postoperative, run by Nilay Er at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the anti-inflammatory effect of platelet-rich fibrin (PRF) applied to the extraction socket after impacted mandibular third molar surgery with subjective and objective parameters. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Complication, Pain, Postoperative, Edema Face
- What is being tested?
- Platelet rich fibrin application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2019to 22 Aug 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- not have any systemic disease that will prevent tissue healing
- no history of regular drug use
- no drug allergies
- not smoking
- not being pregnant
- having bilateral mandibular third molar tooth in class II, position B and C position according to Pell \& Gregory classification with the same root form, position and level of impaction
- no signs of abscess, pericoronitis or inflammation before extraction
Who cannot join
- pregnancy
- having a chronic disease
- having a local infection in the impacted tooth area
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Investigation of Anti-inflammatory Effect of Platelet-Rıch Fıbrın After Mandibular Wisdom Tooth Surgery
This study evaluated the anti-inflammatory effect of platelet-rich fibrin (PRF) applied to the extraction socket after impacted mandibular third molar surgery with subjective and objective parameters. A total of 48 patients who had fully impacted wisdom teeth in bilateral and similar positions were included in the study. The control group was formed with the standard extraction of the lower third molars, and the PRF group was formed with local PRF application in addition to standard impacted tooth surgery (n=96). The anti-inflammatory activity of PRF on postoperative 2nd and 7th days was evaluated subjectively by clinical parameters and objectively by biochemical parameters.
Subjective parameters were pain assesment, swelling measurements on the face and limitation of mouth opening. Objective data is the analysis of serum values and anti-inflammatory markers in the blood.
Read the detailed description
Operations All surgical procedures were performed by the same surgeon, with the same flap design and the same surgical technique. 2 ml of a local anesthetic solution containing 40 mg/ml articaine HCl and 0.006 mg/ml epinephrine HCl was used for N. alveolaris inferior and N. buccalis blockage. The mucoperiosteal flap was removed by making a horizontal incision starting from the retromolar region, through horizontally in the buccal, circular around the neck of the mandibular second molar, and continuing vertically at the mesial half of the mandibular second molar tooth. Alveolotomy and/or division of teeth and/or roots were performed with sterile tungsten carbide burs with an electric controlled motor rotating at 20,000 rpm under 0.9% saline irrigation during operation. Roots were removed from the alveoli with the help of a bein elevator placed on the buccal and/or mesial parts of the teeth. After tooth extraction, the bone, soft tissue residues, and debris in the area were removed, and the socket was irrigated with 0.9% saline. In the control group, primary suturing was performed after bleeding control without any application to the extraction socket, while in the PRF group, PRF was applied to the socket just before suturing (Fig 2). All patients were prescribed antibiotics (amoxicillin-clavulanic acid, 1gr, 2x1) (Augmentin-BID, GlaxoSmithKline, London, England), analgesic (Acetaminophen, 500 mg, 3x1) (Parol, Atabay, Istanbul, Turkey) and mouthwash (120 mg %0.12 chlorhexidine gluconate and 150 mg %0.15 benzydamine hydrochloride, 200 ml, 3x1) (Kloroben, Drogsan, Ankara, Turkey) after the surgical procedure.
PRF Preparation Blood sampling was performed through the peripheral antecubital vein by selecting a suitable branule for the patient's vascular structure with a closed vacuum system. PRFs were prepared according to the method of Choukron et al.(2001). 10 ml blood samples were inserted in a centrifuge device (Intra-Lock International Inc., Boca Raton, USA), under 2700 rpm for 12 min using high speed. The platelet-rich fibrin layer remaining between the acellular plasma and red blood cells in the tube was separated with the help of scissors or a scalpel.
Obtaining edema, pain, and serum marker data A visual analog scale (VAS) of 100 mm was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days, with 0 indicating no pain and 100 indicating the worst pain they had ever experienced. In order to evaluate the severity of edema, the tragus - buccal comissura and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded. To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups. The progression of swelling and trismus was measured in millimeters and evaluated by comparing with the value obtained at baseline14.
For objective data, ESR values were measured using the Vision ESR analyzer (YHLO Biotech Co., Shenzhen, China), and CRP values were measured using the BN II nephelometric analyzer (Siemens Healthcare Diagnostics, Marburg, Germany). IL-6 levels (pg/ml) were determined using the Human IL-6 Elisa Kit (Elabscience Biotechnology Co., Wuhan, China) and TNF-a levels (pg/ml) were determined using the Human TNF-α Elisa Kit (Elabscience Biotechnology Co., was measured using Wuhan, China).
Statistical Evaluation Data were analyzed with the IBM SPSS® V23 (IBM Company, Chicago, IL, United States) package program. Mann-Whitney U test was used to compare non-normally distributed data according to paired groups, and an independent two-sample t-test was used to compare normally distributed data. The significance level was taken as p<0.05.
- Conditions
- Surgical Complication, Pain, Postoperative, Edema Face
- Being tested
- Platelet rich fibrin application
- Keywords
- platelet-rich-fibrin, edema, Serum markers, trismus
- Medical subject headings
- Pain, Postoperative, Edema, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin applicationOther
PRFs were prepared by obtaining10 ml blood samples from each patinet and inserting them in a centrifuge device (Intra-Lock International Inc., Boca Raton, USA), under 2700 rpm for 12 min using high speed. The platelet-rich fibrin layer remaining between the acellular plasma and red blood cells in the tube was separated with the help of scissors or a scalpel. After the tooth extraction in the experimental group PRF located to the extraction socket.
| Study group | Role | What they receive |
|---|---|---|
| 1- PRF | Experimental | After wisdom tooth extraction PRF located to the extraction socket Receives: Other: Platelet rich fibrin application |
| PRF free | No intervention | Only surgical procedure of the wisdom tooth extraction is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema measurement
In order to evaluate the severity of edema, the tragus - mouth corner and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded.
Measured: 2nd day posoperatively
Edema measurement
In order to evaluate the severity of edema, the tragus - mouth corner and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded.
Measured: 7th day posoperatively
Trismus measurement
To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups.
Measured: 2nd day postoperatively
Trismus measurement
To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups.
Measured: 7th day postoperatively
Pain assesment
A visual analog scale (VAS) (Validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain") was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days.
Measured: 2nd day postoperatively
Pain assesment
A visual analog scale (VAS) (Validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain") was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days.
Measured: 7th day postoperatively
Erythrocyte sedimentation rate (ESR)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 2nd day postoperatively
Erythrocyte sedimentation rate (ESR)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 7th day postoperatively
C-reactive protein (CRP)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 2nd day postoperatively
C-reactive protein (CRP)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 7th day postoperatively
interleukin 6 (IL-6)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 2nd day postoperatively
interleukin 6 (IL-6)
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 7th day postoperatively
tumor necrosis factor-alpha (TNF-α )
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 2nd day postoperatively
tumor necrosis factor-alpha (TNF-α )
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Measured: 7th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start10 Oct 2019
- Primary completion10 Feb 2020
- Study completion22 Aug 2021
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 Surgical ComplicationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilay Er
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nilay Er, Trakya University
- Investigators
- Nilay Er, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336578
- Sponsor's protocol ID
- PRF2022
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.
PubMed 21740371Dar MM, Shah AA, Najar AL, Younis M, Kapoor M, Dar JI. Healing Potential of Platelet Rich Fibrin in Impacted Mandibular Third Molar Extraction Sockets. Ann Maxillofac Surg. 2018 Jul-Dec;8(2):206-213. doi: 10.4103/ams.ams_181_18.
PubMed 30693233Ozgul O, Senses F, Er N, Tekin U, Tuz HH, Alkan A, Kocyigit ID, Atil F. Efficacy of platelet rich fibrin in the reduction of the pain and swelling after impacted third molar surgery: randomized multicenter split-mouth clinical trial. Head Face Med. 2015 Nov 26;11:37. doi: 10.1186/s13005-015-0094-5.
PubMed 26607842Litao MK, Kamat D. Erythrocyte sedimentation rate and C-reactive protein: how best to use them in clinical practice. Pediatr Ann. 2014 Oct;43(10):417-20. doi: 10.3928/00904481-20140924-10.
PubMed 25290132Sahibzada HA, Khurshid Z, Khan RS, Naseem M, Siddique KM, Mali M, Zafar MS. Salivary IL-8, IL-6 and TNF-alpha as Potential Diagnostic Biomarkers for Oral Cancer. Diagnostics (Basel). 2017 Apr 9;7(2):21. doi: 10.3390/diagnostics7020021.
PubMed 28397778
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Investigation of Anti-inflammatory Effect of Platelet-Rıch Fıbrın After Mandibular Wisdom Tooth Surgery
- ClinicalTrials.gov ID
- NCT05336578
- Acronym / sponsor ID
- PRF2022
- Conditions
- Surgical Complication, Pain, Postoperative, Edema Face
- Keywords
- platelet-rich-fibrin, edema, Serum markers, trismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nilay ErUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 22 Aug 2021 (actual)
- First posted
- 20 Apr 2022 (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 study evaluated the anti-inflammatory effect of platelet-rich fibrin (PRF) applied to the extraction socket after impacted mandibular third molar surgery with subjective and objective parameters. A total of 48 patients who had fully impacted wisdom teeth in bilateral and similar positions were included in the study. The control group was formed with the standard extraction of the lower third molars, and the PRF group was formed with local PRF application in addition to standard impacted tooth surgery (n=96). The anti-inflammatory activity of PRF on postoperative 2nd and 7th days was evaluated subjectively by clinical parameters and objectively by biochemical parameters.
Subjective parameters were pain assesment, swelling measurements on the face and limitation of mouth opening. Objective data is the analysis of serum values and anti-inflammatory markers in the blood.
Detailed description
Operations All surgical procedures were performed by the same surgeon, with the same flap design and the same surgical technique. 2 ml of a local anesthetic solution containing 40 mg/ml articaine HCl and 0.006 mg/ml epinephrine HCl was used for N. alveolaris inferior and N. buccalis blockage. The mucoperiosteal flap was removed by making a horizontal incision starting from the retromolar region, through horizontally in the buccal, circular around the neck of the mandibular second molar, and continuing vertically at the mesial half of the mandibular second molar tooth. Alveolotomy and/or division of teeth and/or roots were performed with sterile tungsten carbide burs with an electric controlled motor rotating at 20,000 rpm under 0.9% saline irrigation during operation. Roots were removed from the alveoli with the help of a bein elevator placed on the buccal and/or mesial parts of the teeth. After tooth extraction, the bone, soft tissue residues, and debris in the area were removed, and the socket was irrigated with 0.9% saline. In the control group, primary suturing was performed after bleeding control without any application to the extraction socket, while in the PRF group, PRF was applied to the socket just before suturing (Fig 2). All patients were prescribed antibiotics (amoxicillin-clavulanic acid, 1gr, 2x1) (Augmentin-BID, GlaxoSmithKline, London, England), analgesic (Acetaminophen, 500 mg, 3x1) (Parol, Atabay, Istanbul, Turkey) and mouthwash (120 mg %0.12 chlorhexidine gluconate and 150 mg %0.15 benzydamine hydrochloride, 200 ml, 3x1) (Kloroben, Drogsan, Ankara, Turkey) after the surgical procedure.
PRF Preparation Blood sampling was performed through the peripheral antecubital vein by selecting a suitable branule for the patient's vascular structure with a closed vacuum system. PRFs were prepared according to the method of Choukron et al.(2001). 10 ml blood samples were inserted in a centrifuge device (Intra-Lock International Inc., Boca Raton, USA), under 2700 rpm for 12 min using high speed. The platelet-rich fibrin layer remaining between the acellular plasma and red blood cells in the tube was separated with the help of scissors or a scalpel.
Obtaining edema, pain, and serum marker data A visual analog scale (VAS) of 100 mm was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days, with 0 indicating no pain and 100 indicating the worst pain they had ever experienced. In order to evaluate the severity of edema, the tragus - buccal comissura and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded. To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups. The progression of swelling and trismus was measured in millimeters and evaluated by comparing with the value obtained at baseline14.
For objective data, ESR values were measured using the Vision ESR analyzer (YHLO Biotech Co., Shenzhen, China), and CRP values were measured using the BN II nephelometric analyzer (Siemens Healthcare Diagnostics, Marburg, Germany). IL-6 levels (pg/ml) were determined using the Human IL-6 Elisa Kit (Elabscience Biotechnology Co., Wuhan, China) and TNF-a levels (pg/ml) were determined using the Human TNF-α Elisa Kit (Elabscience Biotechnology Co., was measured using Wuhan, China).
Statistical Evaluation Data were analyzed with the IBM SPSS® V23 (IBM Company, Chicago, IL, United States) package program. Mann-Whitney U test was used to compare non-normally distributed data according to paired groups, and an independent two-sample t-test was used to compare normally distributed data. The significance level was taken as p<0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- PRF | Experimental | Other: Platelet rich fibrin applicationAfter wisdom tooth extraction PRF located to the extraction socket |
| PRF free | No intervention | –Only surgical procedure of the wisdom tooth extraction is performed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- not have any systemic disease that will prevent tissue healing
- no history of regular drug use
- no drug allergies
- not smoking
- not being pregnant
Key exclusion criteria (4 listed)
- pregnancy
- having a chronic disease
- having a local infection in the impacted tooth area
- smoking
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 |
|---|---|---|
| Platelet rich fibrin applicationPRFs were prepared by obtaining10 ml blood samples from each patinet and inserting them in a centrifuge device (Intra-Lock International Inc., Boca Raton, USA), under 2700 rpm for 12 min using high speed. The platelet-rich fibrin layer remaining between the acellular plasma and red blood cells in the tube was separated with the help of scissors or a scalpel. After the tooth extraction in the experimental group PRF located to the extraction socket. | Other | 1- PRF |
Primary outcome
Edema measurement
Time frame: 2nd day posoperatively
In order to evaluate the severity of edema, the tragus - mouth corner and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded.
Edema measurement
Time frame: 7th day posoperatively
In order to evaluate the severity of edema, the tragus - mouth corner and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded.
Trismus measurement
Time frame: 2nd day postoperatively
To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups.
Trismus measurement
Time frame: 7th day postoperatively
To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups.
Pain assesment
Time frame: 2nd day postoperatively
A visual analog scale (VAS) (Validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain") was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days.
Pain assesment
Time frame: 7th day postoperatively
A visual analog scale (VAS) (Validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain") was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days.
Erythrocyte sedimentation rate (ESR)
Time frame: 2nd day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Erythrocyte sedimentation rate (ESR)
Time frame: 7th day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
C-reactive protein (CRP)
Time frame: 2nd day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
C-reactive protein (CRP)
Time frame: 7th day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
interleukin 6 (IL-6)
Time frame: 2nd day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
interleukin 6 (IL-6)
Time frame: 7th day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
tumor necrosis factor-alpha (TNF-α )
Time frame: 2nd day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
tumor necrosis factor-alpha (TNF-α )
Time frame: 7th day postoperatively
A serum marker for analysing acute phase response, as it is necessary for initiating the inflammatory response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Results publication: PubMed 21740371Del Corso M, Vervelle A, Simonpieri A, Jimbo R, Inchingolo F, Sammartino G, Dohan Ehrenfest DM. Current knowledge and perspectives for the use of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in oral and maxillofacial surgery part 1: Periodontal and dentoalveolar surgery. Curr Pharm Biotechnol. 2012 Jun;13(7):1207-30. doi: 10.2174/138920112800624391.
- Results publication: PubMed 30693233Dar MM, Shah AA, Najar AL, Younis M, Kapoor M, Dar JI. Healing Potential of Platelet Rich Fibrin in Impacted Mandibular Third Molar Extraction Sockets. Ann Maxillofac Surg. 2018 Jul-Dec;8(2):206-213. doi: 10.4103/ams.ams_181_18.
- Results publication: PubMed 26607842Ozgul O, Senses F, Er N, Tekin U, Tuz HH, Alkan A, Kocyigit ID, Atil F. Efficacy of platelet rich fibrin in the reduction of the pain and swelling after impacted third molar surgery: randomized multicenter split-mouth clinical trial. Head Face Med. 2015 Nov 26;11:37. doi: 10.1186/s13005-015-0094-5.
- Results publication: PubMed 25290132Litao MK, Kamat D. Erythrocyte sedimentation rate and C-reactive protein: how best to use them in clinical practice. Pediatr Ann. 2014 Oct;43(10):417-20. doi: 10.3928/00904481-20140924-10.
- Results publication: PubMed 28397778Sahibzada HA, Khurshid Z, Khan RS, Naseem M, Siddique KM, Mali M, Zafar MS. Salivary IL-8, IL-6 and TNF-alpha as Potential Diagnostic Biomarkers for Oral Cancer. Diagnostics (Basel). 2017 Apr 9;7(2):21. doi: 10.3390/diagnostics7020021.
- Individual participant dataSharing planned: No
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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.
Nilay Er principal investigator
Trakya 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 Platelet rich fibrin application in people with Surgical Complication and Pain, Postoperative, run by Nilay Er 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 20 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema measurement (time frame: 2nd day posoperatively). The study lists 14 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 NCT05336578, 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 20 Apr 2022.