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Simvastatin and Metformin in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo gel
1% Metformin
1.2% Simvastatin
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 Simvastatin, Metformin, Chronic periodontitis

Eligibility Criteria

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

Inclusion Criteria:

  • Systemically healthy subjects
  • Pocket depth ≥ 5 mm
  • Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months

Exclusion Criteria:

  • Subjects allergic to MF or SMV
  • Those on systemic MF or SMV therapy
  • Subjects with aggressive periodontitis
  • Immunocompromised subjects
  • Use of tobacco in any form, alcoholics
  • Lactating and pregnant females

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo Group

    1% Metformin

    1.2% Simvastatin

    Arm Description

    Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.

    1% metformin gel to be delivered at baseline, 3, 6 and 9 months.

    1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.

    Outcomes

    Primary Outcome Measures

    Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
    Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.

    Secondary Outcome Measures

    Plaque index will be measured at 3, 6 and 9 months
    Modified sulcular bleeding index at 3, 6 and 9 months
    Probing pocket depth at 3, 6 and 9 months
    Clinical attachment level at 3, 6 and 9 months

    Full Information

    First Posted
    November 30, 2014
    Last Updated
    February 20, 2015
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02372656
    Brief Title
    Simvastatin and Metformin in Chronic Periodontitis
    Official Title
    Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (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
    This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.
    Detailed Description
    Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel. Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group. Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Simvastatin, Metformin, Chronic periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.
    Arm Title
    1% Metformin
    Arm Type
    Active Comparator
    Arm Description
    1% metformin gel to be delivered at baseline, 3, 6 and 9 months.
    Arm Title
    1.2% Simvastatin
    Arm Type
    Active Comparator
    Arm Description
    1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo gel
    Other Intervention Name(s)
    Placebo group
    Intervention Description
    Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
    Intervention Type
    Drug
    Intervention Name(s)
    1% Metformin
    Other Intervention Name(s)
    1% Metformin group
    Intervention Description
    1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
    Intervention Type
    Drug
    Intervention Name(s)
    1.2% Simvastatin
    Other Intervention Name(s)
    1.2% Simvastatin group
    Intervention Description
    1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
    Primary Outcome Measure Information:
    Title
    Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
    Description
    Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.
    Time Frame
    Baseline to 6 months and Baseline to 9 months
    Secondary Outcome Measure Information:
    Title
    Plaque index will be measured at 3, 6 and 9 months
    Time Frame
    3,6 and 9 months
    Title
    Modified sulcular bleeding index at 3, 6 and 9 months
    Time Frame
    3 , 6 and 9 months
    Title
    Probing pocket depth at 3, 6 and 9 months
    Time Frame
    3 , 6 and 9 months
    Title
    Clinical attachment level at 3, 6 and 9 months
    Time Frame
    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: Systemically healthy subjects Pocket depth ≥ 5 mm Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months Exclusion Criteria: Subjects allergic to MF or SMV Those on systemic MF or SMV therapy Subjects with aggressive periodontitis Immunocompromised subjects Use of tobacco in any form, alcoholics Lactating and pregnant females

    12. IPD Sharing Statement

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    Simvastatin and Metformin in Chronic Periodontitis

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