Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

NCT05409495 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/93
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet-Rich Fibrin

Keywords

chronic periodontitis; growth factors; guided tissue regeneration; periodontal; platelet-derived growth factor; platelet-rich fibrin

Outcome Measures

Primary Outcomes (5)

• site-specific plaque index (PI) (Silness & Loe)

  measurement of plaque accumulated on the tooth surface

  9 month

• modified sulcus bleeding index (mSBI)

  assessment of bleeding gums

  9 month

• probing depth from the gingival margin (PD)

  evaluated from the gingival margin to the base of the pocket

  9 month

• gingival marginal level (GML)

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

  9 month

• relative attachment level (RAL)

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

  9 month

Secondary Outcomes (3)

• fibroblast growth factors (FGF-2)

  12 weeks

• platelet-derived growth factors (PDGF-BB)

  12 weeks

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

  12 weeks

Other Outcomes (2)

• While examining the radiographic intraosseous defect, the distance between the alveolar bone crest and the base of the defect was taken into account. This distance (IBD) was evaluated using computer aided software.

  9 month

• Also while measuring periodontal bone support (PBS) using radiographic images used Image Tool v.3.0 (UTHSCSA).

  9 month

Study Arms (2)

The control group treated with open flap debridement (OFD)

EXPERIMENTAL

The control group periodontal intrabony defects were treated with open flap debridement (OFD) only.

Procedure: periodontal surgical procedure (open flap debridement)

The test group treated with OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)

EXPERIMENTAL

The test group periodontal intrabony defects were treated with open flap debridement (OFD) with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined.

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

Interventions

periodontal surgical procedure (open flap debridement) PROCEDURE

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.

The control group treated with open flap debridement (OFD)

periodontal surgical procedure (OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)) PROCEDURE

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.

The test group treated with OFD +autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Dentistry Department of Peirodontology

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (23)

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  PMID: 9371122 RESULT

• 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.

  PMID: 19187989 RESULT

• 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.

  PMID: 16504850 RESULT

• 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.

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• 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.

  PMID: 6437009 RESULT

• 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.

  PMID: 24945603 RESULT

• 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.

  PMID: 27477110 RESULT

• 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.

  PMID: 24667430 RESULT

• 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.

  PMID: 26809431 RESULT

• 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.

  PMID: 23143637 RESULT

• 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.

  PMID: 27747711 RESULT

• Dohan Ehrenfest DM, Bielecki T, Jimbo R, Barbe G, Del Corso M, Inchingolo F, Sammartino G. Do the fibrin architecture and leukocyte content influence the growth factor release of platelet concentrates? An evidence-based answer comparing a pure platelet-rich plasma (P-PRP) gel and a leukocyte- and platelet-rich fibrin (L-PRF). Curr Pharm Biotechnol. 2012 Jun;13(7):1145-52. doi: 10.2174/138920112800624382.

  PMID: 21740377 RESULT

• Su CY, Kuo YP, Tseng YH, Su CH, Burnouf T. In vitro release of growth factors from platelet-rich fibrin (PRF): a proposal to optimize the clinical applications of PRF. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jul;108(1):56-61. doi: 10.1016/j.tripleo.2009.02.004. Epub 2009 May 17.

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• Clipet F, Tricot S, Alno N, Massot M, Solhi H, Cathelineau G, Perez F, De Mello G, Pellen-Mussi P. In vitro effects of Choukroun's platelet-rich fibrin conditioned medium on 3 different cell lines implicated in dental implantology. Implant Dent. 2012 Feb;21(1):51-6. doi: 10.1097/ID.0b013e31822b9cb4.

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• Dohan Ehrenfest DM, Pinto NR, Pereda A, Jimenez P, Corso MD, Kang BS, Nally M, Lanata N, Wang HL, Quirynen M. The impact of the centrifuge characteristics and centrifugation protocols on the cells, growth factors, and fibrin architecture of a leukocyte- and platelet-rich fibrin (L-PRF) clot and membrane. Platelets. 2018 Mar;29(2):171-184. doi: 10.1080/09537104.2017.1293812. Epub 2017 Apr 24.

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MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Didem Ozkal Eminoglu, Dr

  Atatürk University Faculty of Dentistry Department of Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 8, 2022
• Study Start: April 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 15, 2022
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: There is no specific time restriction for this.
• Access Criteria: There is no specific time criterion for this.

Locations

TU (1)