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1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
1.2% Atorvastatin local drug delivery
1.2% simvastatin local drug delivery
Placebo local drug delivery
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 focused on measuring Chronic periodontitis, Local drug delivery,

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months

Exclusion Criteria:

  • Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Sham Comparator

    Placebo Comparator

    Arm Label

    Atorvastatin

    Simvastatin

    Placebo

    Arm Description

    1.2% atorvastatin local drug delivery

    1.2% simvastatin local drug delivery

    Placebo local drug delivery

    Outcomes

    Primary Outcome Measures

    Change in Radiographic intra-bony defect depth.
    The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect.

    Secondary Outcome Measures

    Change in Probing depth.
    Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months.
    Change in Relative attachment level
    Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months.
    Change in mSBI (gingival index)
    modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure.
    Change in plaque index
    Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable.

    Full Information

    First Posted
    February 5, 2014
    Last Updated
    February 9, 2014
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02060032
    Brief Title
    1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
    Official Title
    COMPARATIVE EVALUATION OF CLINICAL EFFICACY OF SUBGINGIVALLY DELIVERED 1.2% ATORVASTATIN AND 1.2% SIMVASTATIN IN TREATMENT OF CHRONIC PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (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
    Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis. Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Chronic periodontitis, Local drug delivery,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    1.2% atorvastatin local drug delivery
    Arm Title
    Simvastatin
    Arm Type
    Sham Comparator
    Arm Description
    1.2% simvastatin local drug delivery
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo local drug delivery
    Intervention Type
    Drug
    Intervention Name(s)
    1.2% Atorvastatin local drug delivery
    Intervention Type
    Drug
    Intervention Name(s)
    1.2% simvastatin local drug delivery
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo local drug delivery
    Primary Outcome Measure Information:
    Title
    Change in Radiographic intra-bony defect depth.
    Description
    The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect.
    Time Frame
    9 months from baseline
    Secondary Outcome Measure Information:
    Title
    Change in Probing depth.
    Description
    Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months.
    Time Frame
    9 months from baseline
    Title
    Change in Relative attachment level
    Description
    Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months.
    Time Frame
    9 months from baseline
    Title
    Change in mSBI (gingival index)
    Description
    modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure.
    Time Frame
    9 months from baseline
    Title
    Change in plaque index
    Description
    Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable.
    Time Frame
    9 months from baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months Exclusion Criteria: Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Avani R Pradeep, MDS
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

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