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Platelet-Rich FibrinNCT05409495

Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

A study testing periodontal surgical procedure (open flap debridement) and periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)) in people with Platelet-Rich Fibrin, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the possible effect of blood group distribution on the content of blood biomaterial was investigated. 64 volunteers were included in the study. Various parameters were evaluated. As a result, it was concluded that blood group distribution does not affect blood biomaterial content. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Platelet-Rich Fibrin
What is being tested?
periodontal surgical procedure (open flap debridement) and periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2021to 15 Feb 2022
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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1)Patients with bilaterally similar periodontal intrabone defects (IBDs)

Who cannot join

  • Who did not show the necessary oral hygiene during the non-surgical periodontal treatment process,
  • history of periodontal therapy in the preceding 1 year,
  • presence of devital tooth, Grade II, or higher mobility of the tooth, and less than 3 bone walls or a defect in the furcation at the site of the bone defect,
  • history of any systemic diseases that can alter the course of the periodontal disease,
  • smokers,
  • use of antibiotics,
  • pregnant/lactating women.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Atatürk University Faculty of Dentistry Department of Peirodontology

    Erzurum, 25240

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Titanium- Platelet Rich Fibrin in Periodontal Intrabony Defects: A Randomized Controlled Split-Mouth Clinical Study

In this study, the possible effect of blood group distribution on the content of blood biomaterial was investigated. 64 volunteers were included in the study. Various parameters were evaluated. As a result, it was concluded that blood group distribution does not affect blood biomaterial content.

Read the detailed description

The aim of this split-mouth, randomized, and controlled study was to compare open flap debridement (OFD) alone against OFD with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined in treating intrabony defects (IBD). Subjects were 20 systemically healthy patients with chronic periodontitis according to 2017 World Workshop. Bilateral operation sites in patients (40 sites) were randomly selected for OFD alone or OFD+ T-PRF combined. Clinical parameters (probing depth (PD), relative attachment level (RAL), and gingival marginal level(GML)), radiographic parameters (intrabone defects (IBDs) and periodontal bone support (PBS)), and growth factors levels (GFL) in gingival crevicular fluid (GCF) (platelet-derived growth factors (PDGF-BB), fibroblast growth factors (FGF-2), relative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG)) were analyzed. The Wilcoxon signed-rank test, the Student's t-test, the two way ANOVA, and the Tukey post hoc test were used for statistical analysis.

Being tested
periodontal surgical procedure (open flap debridement), periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))
Keywords
chronic periodontitis, growth factors, guided tissue regeneration, periodontal, platelet-derived growth factor, platelet-rich fibrin
Medical subject headings
Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • periodontal surgical procedure (open flap debridement)Procedure or surgery

    All surgical procedures were performed by the second periodontist. 0.12% Chlorhexidine digluconate (CHX) rinse for intraoral antisepsis and a povidone iodine solution was used for extraoral antisepsis. After local anesthesia (2% lidocaine with epinephrine 1:100,000/ Astra, Westbrough, MA) was applied, the full thickness trapezoidal flap was raised large enough to provide adequate view of the defect area. Subgingival debridement and root planning were performed with the use of area-specific curets (Gracey curets, Hu-Friedy), and granulation tissue was removed The IBD area in the control group was closed without applying any material. Then mucoperiosteal flaps were repositioned with sutured with 4/0 monoprolene sutures.

  • periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))Procedure or surgery

    All surgical procedures were performed by the second periodontist. 0.12% Chlorhexidine digluconate (CHX) rinse for intraoral antisepsis and a povidone iodine solution was used for extraoral antisepsis. After local anesthesia (2% lidocaine with epinephrine 1:100,000/ Astra, Westbrough, MA) was applied, the full thickness trapezoidal flap was raised large enough to provide adequate view of the defect area. Subgingival debridement and root planning were performed with the use of area-specific curets (Gracey curets, Hu-Friedy), and granulation tissue was removed (Figure 2a). The blood supply of the defect areas was taken into account. At the test site, IBDs were filled with T-PRF and T-PRF membranes were adapted over the defects both buccally and lingually, in addition to OFD (Figure 2b). Then mucoperiosteal flaps were repositioned with sutured with 4/0 monoprolene sutures.

Study groups in NCT05409495
Study groupRoleWhat they receive
The control group treated with open flap debridement (OFD)ExperimentalThe control group periodontal intrabony defects were treated with open flap debridement (OFD) only.
Receives: Procedure: periodontal surgical procedure (open flap debridement)
The test group treated with OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)ExperimentalThe test group periodontal intrabony defects were treated with open flap debridement (OFD) with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined.
Receives: Procedure: periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF))

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. site-specific plaque index (PI) (Silness & Loe)

    measurement of plaque accumulated on the tooth surface

    Measured: 9 month

  2. modified sulcus bleeding index (mSBI)

    assessment of bleeding gums

    Measured: 9 month

  3. probing depth from the gingival margin (PD)

    evaluated from the gingival margin to the base of the pocket

    Measured: 9 month

  4. gingival marginal level (GML)

    measured from the apical most end of the stent to the crest of the gingival margin

    Measured: 9 month

  5. relative attachment level (RAL)

    evaluated from the cementoenamel junction to the base of the pocket and gingival marginal level

    Measured: 9 month

Secondary outcomes (3)

  1. fibroblast growth factors (FGF-2)

    growth factor affecting periodontal regeneration

    Measured: 12 weeks

  2. platelet-derived growth factors (PDGF-BB)

    growth factor affecting periodontal regeneration

    Measured: 12 weeks

  3. Gingival Crevicular Fluid Collection; The gingival crevicular fluid (GCF) sample was collected to biochemically evaluate the patient's periodontal tissue healing.

    relative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG))

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start1 Apr 2021
  3. Primary completion1 Feb 2022
  4. Study completion15 Feb 2022

Resources

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
Model description
Two different treatment modalities to treat deep periodontal intrabony defects were compared in this split-mouth, randomized, parallel and clinical study. The control group defects were treated with OFD only while the test group defects were treated with OFD supplemented with T-PRF. The same periodontal treatment procedure was applied in both groups, except for the use of T-PRF. Clinical and radiographic parameters were measured from baseline to 9 months after surgery.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409495
Sponsor's protocol ID
B.30.2.ATA.0.01.00/93
Status last verified
Jan 2024
First submitted
17 May 2022
Last updated
10 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: If the data of the study is requested by other researchers, the study supervisor can be contacted.

Publications

  • Cochran DL, Wozney JM. Biological mediators for periodontal regeneration. Periodontol 2000. 1999 Feb;19:40-58. doi: 10.1111/j.1600-0757.1999.tb00146.x.

    PubMed 10321215

  • Dangaria SJ, Ito Y, Walker C, Druzinsky R, Luan X, Diekwisch TG. Extracellular matrix-mediated differentiation of periodontal progenitor cells. Differentiation. 2009 Sep-Oct;78(2-3):79-90. doi: 10.1016/j.diff.2009.03.005. Epub 2009 May 9.

    PubMed 19433344

  • Whitman DH, Berry RL, Green DM. Platelet gel: an autologous alternative to fibrin glue with applications in oral and maxillofacial surgery. J Oral Maxillofac Surg. 1997 Nov;55(11):1294-9. doi: 10.1016/s0278-2391(97)90187-7.

    PubMed 9371122

  • Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.

    PubMed 19187989

  • Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.

    PubMed 16504850

  • Kang YH, Jeon SH, Park JY, Chung JH, Choung YH, Choung HW, Kim ES, Choung PH. Platelet-rich fibrin is a Bioscaffold and reservoir of growth factors for tissue regeneration. Tissue Eng Part A. 2011 Feb;17(3-4):349-59. doi: 10.1089/ten.TEA.2010.0327. Epub 2010 Dec 31.

    PubMed 20799908

  • Bussel JB, Kunicki TJ, Michelson AD. Platelets: New Understanding of Platelet Glycoproteins and Their Role in Disease. Hematology Am Soc Hematol Educ Program. 2000:222-240. doi: 10.1182/asheducation-2000.1.222.

    PubMed 11701544

  • Barbalic M, Dupuis J, Dehghan A, Bis JC, Hoogeveen RC, Schnabel RB, Nambi V, Bretler M, Smith NL, Peters A, Lu C, Tracy RP, Aleksic N, Heeriga J, Keaney JF Jr, Rice K, Lip GY, Vasan RS, Glazer NL, Larson MG, Uitterlinden AG, Yamamoto J, Durda P, Haritunians T, Psaty BM, Boerwinkle E, Hofman A, Koenig W, Jenny NS, Witteman JC, Ballantyne C, Benjamin EJ. Large-scale genomic studies reveal central role of ABO in sP-selectin and sICAM-1 levels. Hum Mol Genet. 2010 May 1;19(9):1863-72. doi: 10.1093/hmg/ddq061. Epub 2010 Feb 18.

    PubMed 20167578

  • Mohanty D, Ghosh K, Marwaha N, Kaur S, Chauhan AP, Das KC. Major blood group antigens--a determinant of factor VIII levels in blood? Thromb Haemost. 1984 Jul 29;51(3):414. No abstract available.

    PubMed 6437009

  • Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.

    PubMed 24945603

  • Chatterjee A, Pradeep AR, Garg V, Yajamanya S, Ali MM, Priya VS. Treatment of periodontal intrabony defects using autologous platelet-rich fibrin and titanium platelet-rich fibrin: a randomized, clinical, comparative study. J Investig Clin Dent. 2017 Aug;8(3). doi: 10.1111/jicd.12231. Epub 2016 Jul 31.

    PubMed 27477110

  • Kim TH, Kim SH, Sandor GK, Kim YD. Comparison of platelet-rich plasma (PRP), platelet-rich fibrin (PRF), and concentrated growth factor (CGF) in rabbit-skull defect healing. Arch Oral Biol. 2014 May;59(5):550-8. doi: 10.1016/j.archoralbio.2014.02.004. Epub 2014 Feb 15.

    PubMed 24667430

  • Kobayashi E, Fluckiger L, Fujioka-Kobayashi M, Sawada K, Sculean A, Schaller B, Miron RJ. Comparative release of growth factors from PRP, PRF, and advanced-PRF. Clin Oral Investig. 2016 Dec;20(9):2353-2360. doi: 10.1007/s00784-016-1719-1. Epub 2016 Jan 25.

    PubMed 26809431

  • Kumar RV, Shubhashini N. Platelet rich fibrin: a new paradigm in periodontal regeneration. Cell Tissue Bank. 2013 Sep;14(3):453-63. doi: 10.1007/s10561-012-9349-6. Epub 2012 Nov 11.

    PubMed 23143637

  • Masuki H, Okudera T, Watanebe T, Suzuki M, Nishiyama K, Okudera H, Nakata K, Uematsu K, Su CY, Kawase T. Growth factor and pro-inflammatory cytokine contents in platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), advanced platelet-rich fibrin (A-PRF), and concentrated growth factors (CGF). Int J Implant Dent. 2016 Dec;2(1):19. doi: 10.1186/s40729-016-0052-4. Epub 2016 Aug 22.

    PubMed 27747711

Questions about this trial

What is this clinical trial studying?

A study testing periodontal surgical procedure (open flap debridement) and periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)) in people with Platelet-Rich Fibrin, run by Ataturk 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 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: finished, as of the sponsor's last update on 10 Jan 2024. 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?

site-specific plaque index (PI) (Silness & Loe) (time frame: 9 month). The study lists 5 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 NCT05409495, which also lists 23 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 10 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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