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Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
open flap debridement (OFD)
Platelet rich fibrin (PRF)
Metformin
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontal Surgery, Periodontal Regeneration, Growth factors, Clinical trials

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Presence of 3- wall intrabony defects ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA] ) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP] ) in asymptomatic molar teeth.

Exclusion Criteria:

  • Aggressive Periodontitis subjects
  • Subjects with systemic conditions known to affect the periodontal status
  • Medications known to affect the outcomes of periodontal therapy
  • Hematological disorders and insufficient platelet count (<200,000/mm3)
  • Pregnancy/lactation
  • Smoking and tobacco use in any form
  • Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index [PI]16 > 1.5) after re-evaluation of Phase I therapy were also excluded from the study.
  • In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    ARM1- open flap debridement (OFD)

    ARM2- open flap debridement plus PRF(Platelet rich fibrin)

    ARM3- open flap debridement plus 1%Metformin

    ARM4- open flap debridement plus PRF plus metformin

    Arm Description

    open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect.

    After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30

    After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30

    After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30

    Outcomes

    Primary Outcome Measures

    radiographic defect depth reduction from baseline to 9 months.
    The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months

    Secondary Outcome Measures

    Change in PD
    PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt
    Change in RAL
    RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base
    Change in GML
    Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe
    Change in mSBI
    mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months
    Cgange in PI
    PI is assessed by noting the amount of plaque and the site of plaque present on the tooth surface at 3,6 and 9 months

    Full Information

    First Posted
    September 27, 2014
    Last Updated
    November 4, 2014
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02283554
    Brief Title
    Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects
    Official Title
    Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Government Dental College and Research Institute, Bangalore

    4. Oversight

    5. Study Description

    Brief Summary
    ABSTRACT: Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects. Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    Periodontal Surgery, Periodontal Regeneration, Growth factors, Clinical trials

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ARM1- open flap debridement (OFD)
    Arm Type
    Placebo Comparator
    Arm Description
    open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect.
    Arm Title
    ARM2- open flap debridement plus PRF(Platelet rich fibrin)
    Arm Type
    Experimental
    Arm Description
    After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30
    Arm Title
    ARM3- open flap debridement plus 1%Metformin
    Arm Type
    Experimental
    Arm Description
    After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30
    Arm Title
    ARM4- open flap debridement plus PRF plus metformin
    Arm Type
    Experimental
    Arm Description
    After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30
    Intervention Type
    Procedure
    Intervention Name(s)
    open flap debridement (OFD)
    Intervention Type
    Other
    Intervention Name(s)
    Platelet rich fibrin (PRF)
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Primary Outcome Measure Information:
    Title
    radiographic defect depth reduction from baseline to 9 months.
    Description
    The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months
    Time Frame
    radiographic defect depth reduction from baseline to 9 months.
    Secondary Outcome Measure Information:
    Title
    Change in PD
    Description
    PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt
    Time Frame
    Assessment of PD at 3,6 and 9 months
    Title
    Change in RAL
    Description
    RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base
    Time Frame
    Assessment of RAL at 3,6 and 9 months
    Title
    Change in GML
    Description
    Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe
    Time Frame
    Assessment of GML at 3,6 and 9 months
    Title
    Change in mSBI
    Description
    mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months
    Time Frame
    Assessment of mSBI at 3,6 and 9 months
    Title
    Cgange in PI
    Description
    PI is assessed by noting the amount of plaque and the site of plaque present on the tooth surface at 3,6 and 9 months
    Time Frame
    Assessment of PI at 3,6 and 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Presence of 3- wall intrabony defects ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA] ) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP] ) in asymptomatic molar teeth. Exclusion Criteria: Aggressive Periodontitis subjects Subjects with systemic conditions known to affect the periodontal status Medications known to affect the outcomes of periodontal therapy Hematological disorders and insufficient platelet count (<200,000/mm3) Pregnancy/lactation Smoking and tobacco use in any form Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index [PI]16 > 1.5) after re-evaluation of Phase I therapy were also excluded from the study. In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.

    12. IPD Sharing Statement

    Learn more about this trial

    Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects

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