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Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Open flap debridement (OFD)
OFD with PRF
OFD with ALN
OFD with ATV
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 Chronic Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

  • Patients with a known systemic disease
  • Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group
  • On systemic ALN/ bisphosphonates or ATV/statin group
  • With aggressive periodontitis
  • Who used tobacco in any form
  • Alcoholics
  • Immunocompromised patients
  • And pregnant or lactating females were excluded from the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Open flap debridement group

    PRF group

    Alendronate group

    Atorvastatin group

    Arm Description

    SRP with Open flap debridement (OFD) alone for treating intrabony defect

    SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect

    SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect

    SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect

    Outcomes

    Primary Outcome Measures

    defect depth reduction (DDR)

    Secondary Outcome Measures

    change in clinical attachment level (CAL)
    change in probing pocket depths (PPD)
    change in plaque index (PI)

    Full Information

    First Posted
    August 3, 2015
    Last Updated
    August 4, 2015
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02516111
    Brief Title
    Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment
    Official Title
    Comparative Evaluation of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Treatment of 2/3-walled Intrabony Defects in Chronic Periodontitis Subjects: a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
    Detailed Description
    Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis. Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.

    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
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open flap debridement group
    Arm Type
    Active Comparator
    Arm Description
    SRP with Open flap debridement (OFD) alone for treating intrabony defect
    Arm Title
    PRF group
    Arm Type
    Active Comparator
    Arm Description
    SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect
    Arm Title
    Alendronate group
    Arm Type
    Active Comparator
    Arm Description
    SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect
    Arm Title
    Atorvastatin group
    Arm Type
    Active Comparator
    Arm Description
    SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect
    Intervention Type
    Procedure
    Intervention Name(s)
    Open flap debridement (OFD)
    Intervention Description
    Oral prophylaxis followed by Open flap debridement (OFD)
    Intervention Type
    Biological
    Intervention Name(s)
    OFD with PRF
    Intervention Description
    Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
    Intervention Type
    Drug
    Intervention Name(s)
    OFD with ALN
    Intervention Description
    Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
    Intervention Type
    Drug
    Intervention Name(s)
    OFD with ATV
    Intervention Description
    Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect
    Primary Outcome Measure Information:
    Title
    defect depth reduction (DDR)
    Time Frame
    Change from baseline to 9 months
    Secondary Outcome Measure Information:
    Title
    change in clinical attachment level (CAL)
    Time Frame
    Change from baseline to 9 months
    Title
    change in probing pocket depths (PPD)
    Time Frame
    Change from baseline to 9 months
    Title
    change in plaque index (PI)
    Time Frame
    Change from baseline to 9 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included Exclusion Criteria: Patients with a known systemic disease Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group On systemic ALN/ bisphosphonates or ATV/statin group With aggressive periodontitis Who used tobacco in any form Alcoholics Immunocompromised patients And pregnant or lactating females were excluded from the study

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment

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