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Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet rich fibrine
Open Flap Debridement
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after initial treatment

Exclusion Criteria:

  • The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Platelet Rich Fibrine

    Open Flap Debridement

    Arm Description

    Platelet Rich Fibrine was applied with open flap debridement in test group.

    Platelet Rich Fibrin was not applied to control groups. Only open flap debridement was applied to control groups.

    Outcomes

    Primary Outcome Measures

    Level of Growth Factor
    Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper

    Secondary Outcome Measures

    Alteration of Clinical Attachment Level
    Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
    Alteration of Periodontal Pocket Depth
    Change from baseline Pocket Depth at 9 months were measured with periodontal probe.

    Full Information

    First Posted
    August 24, 2016
    Last Updated
    September 8, 2016
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02898675
    Brief Title
    Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing
    Official Title
    Investigation of the Contributions of Platelet Rich Fibrin Combined With Open Flap Debridement on Periodontal Healing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.
    Detailed Description
    PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. Also PRF contains many growth factors. PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet Rich Fibrine
    Arm Type
    Experimental
    Arm Description
    Platelet Rich Fibrine was applied with open flap debridement in test group.
    Arm Title
    Open Flap Debridement
    Arm Type
    Active Comparator
    Arm Description
    Platelet Rich Fibrin was not applied to control groups. Only open flap debridement was applied to control groups.
    Intervention Type
    Device
    Intervention Name(s)
    Platelet rich fibrine
    Intervention Description
    Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.
    Intervention Type
    Device
    Intervention Name(s)
    Open Flap Debridement
    Intervention Description
    Only open flap debridement treatment the bone loss limitedly
    Primary Outcome Measure Information:
    Title
    Level of Growth Factor
    Description
    Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Alteration of Clinical Attachment Level
    Description
    Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
    Time Frame
    9 month
    Title
    Alteration of Periodontal Pocket Depth
    Description
    Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
    Time Frame
    9 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after initial treatment Exclusion Criteria: The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yasin ÇİÇEK
    Organizational Affiliation
    Adiyaman University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19228091
    Citation
    Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.
    Results Reference
    background
    PubMed Identifier
    28452623
    Citation
    Arabaci T, Kose O, Albayrak M, Cicek Y, Kizildag A. Advantages of Autologous Platelet-Rich Fibrin Membrane on Gingival Crevicular Fluid Growth Factor Levels and Periodontal Healing: A Randomized Split-Mouth Clinical Study. J Periodontol. 2017 Aug;88(8):771-777. doi: 10.1902/jop.2017.160485. Epub 2017 Apr 28.
    Results Reference
    derived

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    Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing

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