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Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SRP with RSV gel LDD
SRP with ATV gel LDD
SRP with placebo gel LDD
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)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy patients with PD ≥5mm or CA loss ≥4mm 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 statin group;
  • on systemic statin therapy;
  • with aggressive periodontitis;
  • who used tobacco in any form;
  • alcoholics;
  • immunocompromised patients;
  • pregnant or lactating females were excluded from the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Rosuvastatin Group

    Atorvastatin Group

    Placebo group

    Arm Description

    SRP followed by RSV gel LDD

    SRP followed by ATV gel LDD

    SRP followed by placebo gel LDD

    Outcomes

    Primary Outcome Measures

    Change in intrabony defect depth from baseline to 6 months
    Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured

    Secondary Outcome Measures

    Change in plaque index (PI) from baseline to 6 months
    Reduction in plaque index (PI) from baseline to 6 months wiil be measured
    Change in modified sulcus bleeding index (mSBI) from baseline to 6 months
    Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured
    Change in probing depth (PD) from baseline to 6 months
    Reduction in probing depth (PD) from baseline to 6 months wiil be measured
    Change in clinical attachment (CA) level from baseline to 6 months
    Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured

    Full Information

    First Posted
    November 6, 2015
    Last Updated
    November 11, 2015
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02600520
    Brief Title
    Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis
    Official Title
    1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 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 and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
    Detailed Description
    Background: Rosuvastatin (RSV) and Atorvastatin (ATV) 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 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP). Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.

    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
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rosuvastatin Group
    Arm Type
    Active Comparator
    Arm Description
    SRP followed by RSV gel LDD
    Arm Title
    Atorvastatin Group
    Arm Type
    Active Comparator
    Arm Description
    SRP followed by ATV gel LDD
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    SRP followed by placebo gel LDD
    Intervention Type
    Drug
    Intervention Name(s)
    SRP with RSV gel LDD
    Intervention Description
    After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
    Intervention Type
    Drug
    Intervention Name(s)
    SRP with ATV gel LDD
    Intervention Description
    After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
    Intervention Type
    Drug
    Intervention Name(s)
    SRP with placebo gel LDD
    Intervention Description
    After SRP, placebo gel was delivered subgingivally into the pocket
    Primary Outcome Measure Information:
    Title
    Change in intrabony defect depth from baseline to 6 months
    Description
    Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured
    Time Frame
    Baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    Change in plaque index (PI) from baseline to 6 months
    Description
    Reduction in plaque index (PI) from baseline to 6 months wiil be measured
    Time Frame
    Baseline to 6 months
    Title
    Change in modified sulcus bleeding index (mSBI) from baseline to 6 months
    Description
    Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured
    Time Frame
    Baseline to 6 months
    Title
    Change in probing depth (PD) from baseline to 6 months
    Description
    Reduction in probing depth (PD) from baseline to 6 months wiil be measured
    Time Frame
    Baseline to 6 months
    Title
    Change in clinical attachment (CA) level from baseline to 6 months
    Description
    Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured
    Time Frame
    Baseline to 6 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: Systemically healthy patients with PD ≥5mm or CA loss ≥4mm 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 statin group; on systemic statin therapy; with aggressive periodontitis; who used tobacco in any form; alcoholics; immunocompromised patients; pregnant or lactating females were excluded from the study

    12. IPD Sharing Statement

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    Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

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