Platelet-Rich FibrinNCT05753631
Effects of i-PRF on Non-surgical Periodontal Treatment
An observational study of Platelet-Rich Fibrin, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Injectable platelet-rich fibrin, a platelet concentrate in a liquid formulation, has been developed to provide clinicians with ease of use alone or in combination with various biomaterials. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Platelet-Rich Fibrin
- What is being tested?
- non surgical periodontal treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 15 Jan 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemically healthy and stage 3 grade B periodontitis aged 18-65
Who may be able to join
- patients with stage 3 grade B periodontitis
Who cannot join
- patients with systemic disease
- pregnant and breastfeeding
- acute or chronic infection in the past 6 months
- Use of systemic antibiotic therapy in the past 6 months
- use of drugs that can affect periodontal health
- receiving hormone therapy
Show all 9Show fewer
- smokers
- teeth with endodontic lesions
- Teeth with class 2 and 3 mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Injectable Platelet-rich Fibrin (i-PRF) Application on Periodontal Clinical and Biochemical Parameters in Gingival Crevicular Fluid (GCF) in Non-surgical Periodontal Treatment
Injectable platelet-rich fibrin, a platelet concentrate in a liquid formulation, has been developed to provide clinicians with ease of use alone or in combination with various biomaterials. The low-speed centrifugation method provides a significant advantage to the regeneration process with richer platelets, leukocytes, and growth factors. It also contributes to the wound-healing process by increasing vascularization. It is expected that the application of injectable platelet-rich fibrin into the gingival pocket following subgingival curettage in periodontitis patients will positively affect the results of non-surgical periodontal treatment. For this reason, in this study it was aimed to investigate the early effects of injectable PRF applied into the pocket for root surface biomodification following subgingival curettage in periodontal pockets of 6 mm and above, by evaluating both clinical parameters and inflammatory and healing markers in the gingival groove fluid
Read the detailed description
The study was planned as a randomized controlled split-mouth clinical trial. A split-mouth design was used to better assess how the same host responded to two different treatment modalities. Two quadrants with contralateral deep periodontal pockets in each participant were selected and randomly divided into test and control groups.
Test group: Injectable platelet-rich fibrin application into the selected deep periodontal pocket after scaling and root planning (SRP) procedure.
Control group: No agent was applied to the periodontal pocket after scaling and root planning.
On the first visit, clinical periodontal measurements were taken before the SRP procedure. Plague index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were used as clinical periodontal parameters.
After 1 week, the patients were called again for the SRP procedure. Injectable PRF obtained from the intravenous blood sample taken from the antecubital vein of the patients was injected into the deepened periodontal pocket subgingivally after the SRP procedure in the test group. Clinical periodontal measurements at 1 month and 3 months after SRP were repeated.
Gingival crevicular fluid (GCF) samples were taken from selected teeth before the SRP procedure. On the 3rd and 7th day after the SRP, GCF samples were taken again from the same region.
GCF vascular endothelial growth factor (VEGF), tumor necrosis factor-alpha (TNF-α), and interleukin (IL)-10 levels were evaluated by using the ELISA method and compared between groups.
- Conditions
- Platelet-Rich Fibrin
- Being tested
- non surgical periodontal treatment
- Keywords
- platelet-rich fibrin, non-surgical periodontal treatment, wound healing, growth factor, cytokine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non surgical periodontal treatmentProcedure or surgery
Also called i-PRF application, clinical periodontal measurement taken, gingival crevicular fluid obtained
scaling and root planning were applied for non-surgical periodontal treatment i-PRF application: Intravenous blood sample taken from the antecubital vein of the patients was collected in a 10 ml tube and centrifuged at 700 rpm for 3 minutes in a PRF centrifuge device. The PRF obtained from the upper liquid layer formed in the tube was injected subgingival into the deepest point of the pocket after SRP treatment.
Clinical periodontal measurements: plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing, and gingival recession were calculated.
gingival crevicular fluid: Perio papers were placed in the deepest part of the sulcus and left for 30 seconds. After 30 seconds, the paper strips were placed in the periotron device and the volume was calculated.
| Study group | Role | What they receive |
|---|---|---|
| SRP+i-PRF (test) | Injectable platelet-rich fibrin (i-PRF) application into the selected deep periodontal pocket after scaling and root planning (SRP) procedure. Receives: Procedure: non surgical periodontal treatment | |
| SRP (Control) | No agent was applied to the periodontal pocket after scaling and root planning. Receives: Procedure: non surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF VEGF levels in test and control groups
measure and compare the improvement of VEGF in test and control groups by using ELISA
Measured: Change from Baseline GCF VEGF levels at 3rd and 7th days
GCF TNF-alpha levels in test and control groups
measure and compare the improvement of TNF-alpha in test and control groups by using ELISA
Measured: Change from Baseline GCF TNF-alpha levels at 3rd and 7th days
GCF IL-10 levels in test and control groups
measure and compare the improvement of IL-10 in test and control groups by using ELISA
Measured: Change from Baseline GCF IL-10 levels at 3rd and 7th days
Plaque index (PI)
measure and compare the improvement of PI in test and control groups using a scale
Measured: Change from Baseline PI at 3rd and 7th days
Probing depth (PD)
measure the gingival margin to pocket bottom as mm and compare the improvement of PD in test and control groups
Measured: Change from Baseline PD levels at 3rd and 7th days
Gingival index (GI)
measure and compare the improvement of GI in test and control groups using a scale
Measured: Change from Baseline GI at 3rd and 7th days
Bleeding on probing (BOP)
Whether there is bleeding when the periodontal pocket is probed and comparing the improvement in test and control groups
Measured: Change from Baseline BOP at 3rd and 7th days
Clinical attachment level (CAL)
measure the distance from the cemento-enamel line to the bottom of the pocket and compare the improvement in test and control groups
Measured: Change from Baseline CAL at 3rd and 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start2 Feb 2022
- Primary completion15 Nov 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Platelet-Rich FibrinStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSAN LEKTEMUR ALPAN, Pamukkale University
- Investigators
- Gizem Torumtay Cin, PhD, Principal investigator, pamukkale university faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753631
- Sponsor's protocol ID
- 22.02.2022/04
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is planned to be given if requested with a valid reason.
Publications
Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
PubMed 28154995Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
PubMed 16504852Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8.
PubMed 38153510
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Injectable Platelet-rich Fibrin (i-PRF) Application on Periodontal Clinical and Biochemical Parameters in Gingival Crevicular Fluid (GCF) in Non-surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT05753631
- Acronym / sponsor ID
- 22.02.2022/04
- Conditions
- Platelet-Rich Fibrin
- Keywords
- platelet-rich fibrin, non-surgical periodontal treatment, wound healing, growth factor, cytokine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 3 Mar 2023 (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.
Injectable platelet-rich fibrin, a platelet concentrate in a liquid formulation, has been developed to provide clinicians with ease of use alone or in combination with various biomaterials. The low-speed centrifugation method provides a significant advantage to the regeneration process with richer platelets, leukocytes, and growth factors. It also contributes to the wound-healing process by increasing vascularization. It is expected that the application of injectable platelet-rich fibrin into the gingival pocket following subgingival curettage in periodontitis patients will positively affect the results of non-surgical periodontal treatment. For this reason, in this study it was aimed to investigate the early effects of injectable PRF applied into the pocket for root surface biomodification following subgingival curettage in periodontal pockets of 6 mm and above, by evaluating both clinical parameters and inflammatory and healing markers in the gingival groove fluid
Detailed description
The study was planned as a randomized controlled split-mouth clinical trial. A split-mouth design was used to better assess how the same host responded to two different treatment modalities. Two quadrants with contralateral deep periodontal pockets in each participant were selected and randomly divided into test and control groups.
Test group: Injectable platelet-rich fibrin application into the selected deep periodontal pocket after scaling and root planning (SRP) procedure.
Control group: No agent was applied to the periodontal pocket after scaling and root planning.
On the first visit, clinical periodontal measurements were taken before the SRP procedure. Plague index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were used as clinical periodontal parameters.
After 1 week, the patients were called again for the SRP procedure. Injectable PRF obtained from the intravenous blood sample taken from the antecubital vein of the patients was injected into the deepened periodontal pocket subgingivally after the SRP procedure in the test group. Clinical periodontal measurements at 1 month and 3 months after SRP were repeated.
Gingival crevicular fluid (GCF) samples were taken from selected teeth before the SRP procedure. On the 3rd and 7th day after the SRP, GCF samples were taken again from the same region.
GCF vascular endothelial growth factor (VEGF), tumor necrosis factor-alpha (TNF-α), and interleukin (IL)-10 levels were evaluated by using the ELISA method and compared between groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP+i-PRF (test) | – | Procedure: non surgical periodontal treatmentInjectable platelet-rich fibrin (i-PRF) application into the selected deep periodontal pocket after scaling and root planning (SRP) procedure. |
| SRP (Control) | – | Procedure: non surgical periodontal treatmentNo agent was applied to the periodontal pocket after scaling and root planning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemically healthy and stage 3 grade B periodontitis aged 18-65
Key inclusion criteria (1 listed)
- patients with stage 3 grade B periodontitis
Key exclusion criteria (9 listed)
- patients with systemic disease
- pregnant and breastfeeding
- acute or chronic infection in the past 6 months
- Use of systemic antibiotic therapy in the past 6 months
- use of drugs that can affect periodontal health
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 |
|---|---|---|
| non surgical periodontal treatmentAlso: i-PRF application, clinical periodontal measurement taken, gingival crevicular fluid obtainedscaling and root planning were applied for non-surgical periodontal treatment i-PRF application: Intravenous blood sample taken from the antecubital vein of the patients was collected in a 10 ml tube and centrifuged at 700 rpm for 3 minutes in a PRF centrifuge device. The PRF obtained from the upper liquid layer formed in the tube was injected subgingival into the deepest point of the pocket after SRP treatment. Clinical periodontal measurements: plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing, and gingival recession were calculated. gingival crevicular fluid: Perio papers were placed in the deepest part of the sulcus and left for 30 seconds. After 30 seconds, the paper strips were placed in the periotron device and the volume was calculated. | Procedure or surgery | SRP (Control), SRP+i-PRF (test) |
Primary outcome
GCF VEGF levels in test and control groups
Time frame: Change from Baseline GCF VEGF levels at 3rd and 7th days
measure and compare the improvement of VEGF in test and control groups by using ELISA
GCF TNF-alpha levels in test and control groups
Time frame: Change from Baseline GCF TNF-alpha levels at 3rd and 7th days
measure and compare the improvement of TNF-alpha in test and control groups by using ELISA
GCF IL-10 levels in test and control groups
Time frame: Change from Baseline GCF IL-10 levels at 3rd and 7th days
measure and compare the improvement of IL-10 in test and control groups by using ELISA
Plaque index (PI)
Time frame: Change from Baseline PI at 3rd and 7th days
measure and compare the improvement of PI in test and control groups using a scale
Probing depth (PD)
Time frame: Change from Baseline PD levels at 3rd and 7th days
measure the gingival margin to pocket bottom as mm and compare the improvement of PD in test and control groups
Gingival index (GI)
Time frame: Change from Baseline GI at 3rd and 7th days
measure and compare the improvement of GI in test and control groups using a scale
Bleeding on probing (BOP)
Time frame: Change from Baseline BOP at 3rd and 7th days
Whether there is bleeding when the periodontal pocket is probed and comparing the improvement in test and control groups
Clinical attachment level (CAL)
Time frame: Change from Baseline CAL at 3rd and 7th days
measure the distance from the cemento-enamel line to the bottom of the pocket and compare the improvement in test and control groups
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 3 Mar 2023.
- Background: PubMed 28154995Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
- Results publication: PubMed 16504852Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
- Derived from this study: PubMed 38153510Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8.
- Individual participant dataSharing planned: Undecided. It is planned to be given if requested with a valid reason.
Related trials for Platelet-Rich Fibrin
Recruiting
Alveolar Bone Regeneration Using Advanced Platelet-Rich Fibrin Combined With Strontium-Doped Hydroxyapatite
Alveolar Bone Regeneration, Advanced Platelet-Rich Fibrin
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruiting
Microneedling-Assisted i-PRF for Interdental Papilla Deficiency
Interdental Papilla Deficiency
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.
Gizem Torumtay Cin, PhD principal investigator
pamukkale university faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet-Rich Fibrin, run by Pamukkale 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 1 inclusion and 9 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 3 Mar 2023. 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?
GCF VEGF levels in test and control groups (time frame: Change from Baseline GCF VEGF levels at 3rd and 7th days). The study lists 8 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 NCT05753631, which also lists 3 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 3 Mar 2023.