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Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
placebo gel
Aloevera
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 Chronic Periodontitis

Eligibility Criteria

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

Inclusion Criteria:

Systemically healthy patients with sites showing PPD ≥ 5 mm, CAL ≥ 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 AV Those on systemic MF or AV 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

    Group 1

    Group 2

    Group 3

    Arm Description

    Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.

    Aloe vera gel to be delivered at baseline, 6 and 12 months.

    1% metformin gel to be delivered at baseline, 6 and 12 months.

    Outcomes

    Primary Outcome Measures

    Change in Bone defect fill
    Assessed in percentage

    Secondary Outcome Measures

    Change in modified sulcus bleeding index
    scale 0-3
    Change in Plaque index
    scale 0-3
    Change in pocket probing depth
    measured in mm
    Clinical attachment level
    measured in mm

    Full Information

    First Posted
    June 28, 2017
    Last Updated
    June 28, 2017
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03204071
    Brief Title
    Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis
    Official Title
    COMPARATIVE EVALUATION OF SUBGINGIVALLY DELIVERED 1% METFORMIN AND ALOE VERA GEL IN TREATMENT OF INTRABODY DEFECTS IN CHRONIC PERIODONTITIS SUBJECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    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
    Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favorable effect on alveolar bone. AloeVera Gel had also been used in dentistry and showed good results.The present study aims to explore the efficacy of 1% MF gel and aloe vera gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of subjects with chronic periodontitis (CP) with intrabody defects.
    Detailed Description
    Aim: To compare the efficacy of locally delivered 1% MF gel and aloe vera 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: Placebo, aloevera gel(AV) and 1% Metformin (MF)after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 6 and 12 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 12 months interval using computer-aided software Results: Mean PPD reduction and mean CAL gain was found to greater in MF group than AV and placebo group at all visits. The DDR% was greater in MF group as compared to AV and placebo group. Conclusion: There was a greater decrease in mSBI and PPD and more CAL gain at the sites treated with AV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The significant IBD depth reduction effect was seen in case of MFgroup.

    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
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Aloe vera gel to be delivered at baseline, 6 and 12 months.
    Arm Title
    Group 3
    Arm Type
    Active Comparator
    Arm Description
    1% metformin gel to be delivered at baseline, 6 and 12 months.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo gel
    Other Intervention Name(s)
    inactive drug
    Intervention Description
    Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
    Intervention Type
    Drug
    Intervention Name(s)
    Aloevera
    Other Intervention Name(s)
    AV
    Intervention Description
    Oral prophylaxis followed by placement of aloevera gel
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    MF
    Intervention Description
    Oral prophylaxis followed by placement of metformin gel
    Primary Outcome Measure Information:
    Title
    Change in Bone defect fill
    Description
    Assessed in percentage
    Time Frame
    baseline - 6 months & baseline -12 months
    Secondary Outcome Measure Information:
    Title
    Change in modified sulcus bleeding index
    Description
    scale 0-3
    Time Frame
    baseline, 6 & 12 months
    Title
    Change in Plaque index
    Description
    scale 0-3
    Time Frame
    baseline, 6 & 12 months
    Title
    Change in pocket probing depth
    Description
    measured in mm
    Time Frame
    baseline, 6 & 12 months
    Title
    Clinical attachment level
    Description
    measured in mm
    Time Frame
    baseline, 6 & 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy patients with sites showing PPD ≥ 5 mm, CAL ≥ 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 AV Those on systemic MF or AV therapy Subjects with aggressive periodontitis Immunocompromised subjects Use of tobacco in any form, alcoholics Lactating, and pregnant females

    12. IPD Sharing Statement

    Learn more about this trial

    Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

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