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Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atorvastatin (ATV)
Placebo 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

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.

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 ATV or other statins or those taking ATV/other statins systemically were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    SRP plus placebo

    SRP plus Atorvastatin

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    amount of bone fill

    Secondary Outcome Measures

    change in Relative vertical clinical attachment level
    change in RHCAL (relative horizontal clinical attachment level)
    change in probing depth
    change in site specific plaque index
    change in modified sulcus bleeding index

    Full Information

    First Posted
    November 30, 2014
    Last Updated
    March 5, 2015
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02386033
    Brief Title
    Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
    Official Title
    Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 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
    ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects. Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.
    Detailed Description
    Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.

    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
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SRP plus placebo
    Arm Type
    Placebo Comparator
    Arm Description
    SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
    Arm Title
    SRP plus Atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin (ATV)
    Other Intervention Name(s)
    ATV gel
    Intervention Description
    After SRP, ATV gel was delivered subgingivally into the pocket
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Gel
    Intervention Description
    After SRP, placebo gel was delivered subgingivally into the pocket
    Primary Outcome Measure Information:
    Title
    amount of bone fill
    Time Frame
    baseline to 9 months
    Secondary Outcome Measure Information:
    Title
    change in Relative vertical clinical attachment level
    Time Frame
    baseline to 9 months
    Title
    change in RHCAL (relative horizontal clinical attachment level)
    Time Frame
    baseline to 9 months
    Title
    change in probing depth
    Time Frame
    baseline to 9 months
    Title
    change in site specific plaque index
    Time Frame
    baseline to 9 months
    Title
    change in modified sulcus bleeding index
    Time Frame
    baseline to 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars. 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 ATV or other statins or those taking ATV/other statins systemically were excluded.

    12. IPD Sharing Statement

    Learn more about this trial

    Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects

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