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Alendronate Compared to Metformin in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SRP plus Placebo Gel
SRP plus Alendronate gel
SRP plus Metformin gel
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 alendronate, metformin

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All the subjects were systemically healthy
  • subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,
  • vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and
  • subjects with no history of periodontal intervention in the last 6 months.

Exclusion Criteria:

  • patients with systemic diseases like cardiovascular disease
  • diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
  • pregnant/lactating females
  • tobacco users
  • alcoholics
  • patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
  • teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
  • Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    placebo

    Metformin

    Alendronate

    Arm Description

    SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket

    SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally

    SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally

    Outcomes

    Primary Outcome Measures

    bone fill
    amount of bone fill from baseline to 9 months

    Secondary Outcome Measures

    Relative vertical clinical attachment level
    change in Relative vertical clinical attachment level baseline to 9 months
    probing depth
    change in probing depth from baseline to 9 months

    Full Information

    First Posted
    May 19, 2015
    Last Updated
    May 31, 2015
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02461667
    Brief Title
    Alendronate Compared to Metformin in Chronic Periodontitis
    Official Title
    Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 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
    This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.
    Detailed Description
    ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis. Methods: The study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 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
    alendronate, metformin

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
    Arm Title
    Metformin
    Arm Type
    Active Comparator
    Arm Description
    SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally
    Arm Title
    Alendronate
    Arm Type
    Active Comparator
    Arm Description
    SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
    Intervention Type
    Drug
    Intervention Name(s)
    SRP plus Placebo Gel
    Other Intervention Name(s)
    Placebo
    Intervention Description
    After SRP, placebo gel was delivered subgingivally into the pocket
    Intervention Type
    Drug
    Intervention Name(s)
    SRP plus Alendronate gel
    Other Intervention Name(s)
    Alendronate gel
    Intervention Description
    Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket
    Intervention Type
    Drug
    Intervention Name(s)
    SRP plus Metformin gel
    Other Intervention Name(s)
    Metformin gel
    Intervention Description
    Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket
    Primary Outcome Measure Information:
    Title
    bone fill
    Description
    amount of bone fill from baseline to 9 months
    Time Frame
    baseline to 9 months
    Secondary Outcome Measure Information:
    Title
    Relative vertical clinical attachment level
    Description
    change in Relative vertical clinical attachment level baseline to 9 months
    Time Frame
    baseline to 9 months
    Title
    probing depth
    Description
    change in probing depth from baseline to 9 months
    Time Frame
    baseline to 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All the subjects were systemically healthy subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm, vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and subjects with no history of periodontal intervention in the last 6 months. Exclusion Criteria: patients with systemic diseases like cardiovascular disease diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues. pregnant/lactating females tobacco users alcoholics patients with unsatisfactory oral hygiene (plaque index greater than 1.5) teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.

    12. IPD Sharing Statement

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    Alendronate Compared to Metformin in Chronic Periodontitis

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