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Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SRP and Placebo gel
SRP and Atorvastatin
SRP and Alendronate
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 PDs ≥5mm or CALs ≥4 to 6mm 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 the ALN/bisphosphonate group and ATV/statin group;
  • on systemic ALN/bisphosphonate and therapy ATV/statin group;
  • with aggressive periodontitis;
  • who used tobacco in any form;
  • alcoholics;
  • immunocompromised patients;
  • and pregnant or lactating females were excluded from the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo group

    Atorvastatin group

    Alendronate Group

    Arm Description

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

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

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

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

    Full Information

    First Posted
    May 19, 2015
    Last Updated
    May 25, 2015
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02455869
    Brief Title
    Comparison of Alendronate With Atorvastatin in Chronic Periodontitis
    Official Title
    Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin 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
    The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
    Detailed Description
    Background: Alendronate and Atorvastatin 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% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis. Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], 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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo group
    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
    Atorvastatin group
    Arm Type
    Active Comparator
    Arm Description
    SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
    Arm Title
    Alendronate Group
    Arm Type
    Active Comparator
    Arm Description
    Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
    Intervention Type
    Drug
    Intervention Name(s)
    SRP and Placebo gel
    Intervention Description
    After SRP, placebo gel was delivered subgingivally into the pocket
    Intervention Type
    Drug
    Intervention Name(s)
    SRP and Atorvastatin
    Intervention Description
    After SRP, Atorvastatin gel was delivered subgingivally into the pocket
    Intervention Type
    Drug
    Intervention Name(s)
    SRP and Alendronate
    Intervention Description
    After SRP, Alendronate gel was delivered subgingivally into the pocket
    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
    Description
    Plaque index will be measured at 3, 6 and 9 months
    Time Frame
    3,6 and 9 months
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index will be measured at 3, 6 and 9 months
    Time Frame
    3,6 and 9 months]
    Title
    Probing pocket depth
    Description
    Probing pocket depth will be measured at 3, 6 and 9 months
    Time Frame
    3,6 and 9 months]
    Title
    Clinical attachment level
    Description
    Clinical attachment level will be measured 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 patients with PDs ≥5mm or CALs ≥4 to 6mm 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 the ALN/bisphosphonate group and ATV/statin group; on systemic ALN/bisphosphonate and therapy ATV/statin group; with aggressive periodontitis; who used tobacco in any form; alcoholics; immunocompromised patients; and pregnant or lactating females were excluded from the study

    12. IPD Sharing Statement

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    Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

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