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The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid (T-PRF)

Primary Purpose

Chronic Periodontitis, Intrabony Periodontal Defect

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
T-PRF
Allograft
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Angiogenesis, Bilateral infrabony defect, Flap surgery, Titanium-prepared, platelet-rich fibrin

Eligibility Criteria

26 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical Diagnosis of Chronic Periodontitis
  • The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy

Exclusion Criteria:

  • Systemic illnesses
  • Any medications known to affect the outcomes of periodontal surgery
  • Pregnancy and lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    T-PRF+Allograft

    Allograft

    Arm Description

    The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Test group sites were treated with T-PRF+allograft

    The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Control group sites were treated with only allograft

    Outcomes

    Primary Outcome Measures

    Platelet-derived growth factor-BB (ng/µl) , vascular endothelial growth factor-A (ng/µl), fibroblast growth factor-2 (ng/µl), anjiogenin (ng/µl), angiostatin (ng/µl)

    Secondary Outcome Measures

    The Volume of Gingival Crevicular Fluid (microliter)

    Full Information

    First Posted
    February 18, 2016
    Last Updated
    February 22, 2016
    Sponsor
    Kırıkkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02692079
    Brief Title
    The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid
    Acronym
    T-PRF
    Official Title
    The Effect of Titanium-Prepared Platelet-Rich Fibrin (T-PRF) Treatment on the Angiogenic Biomarkers in Gingival Crevicular Fluid (GCF) in Infrabony Defects of Patients With Chronic Periodontitis: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kırıkkale University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF) treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony defects of patients with chronic periodontitis. In each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+T-PRF).
    Detailed Description
    Platelets are the cells initiating the wound healing and also supporting it by secreting various growth factors actively. These growth factors released by platelets act the increase of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound angiogenesis and the activation of macrophages by stimulating cell proliferation signals. Titanium-prepared, platelet-rich fibrin (T-PRF), is a new platelet concentrate, is formed in titanium tubes may be more efficient to activate platelets in comparison with glass tubes.The titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis, Intrabony Periodontal Defect
    Keywords
    Angiogenesis, Bilateral infrabony defect, Flap surgery, Titanium-prepared, platelet-rich fibrin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    T-PRF+Allograft
    Arm Type
    Experimental
    Arm Description
    The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Test group sites were treated with T-PRF+allograft
    Arm Title
    Allograft
    Arm Type
    Experimental
    Arm Description
    The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Control group sites were treated with only allograft
    Intervention Type
    Procedure
    Intervention Name(s)
    T-PRF
    Intervention Description
    Flap Surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Allograft
    Intervention Description
    Flap Surgery
    Primary Outcome Measure Information:
    Title
    Platelet-derived growth factor-BB (ng/µl) , vascular endothelial growth factor-A (ng/µl), fibroblast growth factor-2 (ng/µl), anjiogenin (ng/µl), angiostatin (ng/µl)
    Time Frame
    Within the first 30 days after surgery
    Secondary Outcome Measure Information:
    Title
    The Volume of Gingival Crevicular Fluid (microliter)
    Time Frame
    Within the first 30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical Diagnosis of Chronic Periodontitis The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy Exclusion Criteria: Systemic illnesses Any medications known to affect the outcomes of periodontal surgery Pregnancy and lactation

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid

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