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Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

Primary Purpose

Chronic Periaortitis, Intrabony Periodontal Defect

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
DFDBA
DFDBA with atorvastatin
Sponsored by
Kamineni Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periaortitis focused on measuring Chronic periodontitis, atorvastatin, intrabony defect

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Systemically healthy individual based on personal and medical history.
  2. Presentation of untreated Chronic Periodontitis with intrabony defect having probing pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of angular bone loss.

Exclusion Criteria:

  1. Patients diagnosed and treated for systemic disease
  2. Pregnant and Lactating women
  3. Smokers
  4. History of allergy to statin group or patients on systemic statin therapy.
  5. History of antibiotic or periodontal therapy for the past 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    DFDBA

    DFDBA with Atorvastatin

    Arm Description

    13 intrabony defects in chronic periodontitis patients were treated with DFDBA

    13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.

    Outcomes

    Primary Outcome Measures

    bone fill in mm was measured by taking radiographs

    Secondary Outcome Measures

    Full Information

    First Posted
    December 28, 2016
    Last Updated
    January 3, 2017
    Sponsor
    Kamineni Institute of Dental Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03009097
    Brief Title
    Atorvastatin as an Adjunct to DFDBA in Intrabony Defects
    Official Title
    "Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects" - A Clinico Radiological Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 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
    Kamineni Institute of Dental Sciences

    4. Oversight

    5. Study Description

    Brief Summary
    Periodontitis is a major oral health problem which leads to the progressive destruction of periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common form of regenerative periodontal therapy is the use of bone grafts which stimulate bone formation by the processes of osteoinduction and osteoconduction. Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti oxidant properties. Very few studies exist evaluating the beneficiary effects of grafts if combined with the statins which might enhance the regeneration by bone grafts. Hence, the present study was carried out in an attempt to comparatively evaluate clinically and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the treatment of intrabony defects.
    Detailed Description
    A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by radiographs, were selected for the study after taking an informed consent. The selected sites were randomized in 2 treatment groups. Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with allograft (DFDBA) in combination with Atorvastatin gel. Clinical parameters like probing depth and clinical attachment level and radiological assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periaortitis, Intrabony Periodontal Defect
    Keywords
    Chronic periodontitis, atorvastatin, intrabony defect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DFDBA
    Arm Type
    Active Comparator
    Arm Description
    13 intrabony defects in chronic periodontitis patients were treated with DFDBA
    Arm Title
    DFDBA with Atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.
    Intervention Type
    Biological
    Intervention Name(s)
    DFDBA
    Other Intervention Name(s)
    Allograft
    Intervention Description
    13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)
    Intervention Type
    Drug
    Intervention Name(s)
    DFDBA with atorvastatin
    Other Intervention Name(s)
    atorvastatin gel
    Intervention Description
    13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
    Primary Outcome Measure Information:
    Title
    bone fill in mm was measured by taking radiographs
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy individual based on personal and medical history. Presentation of untreated Chronic Periodontitis with intrabony defect having probing pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of angular bone loss. Exclusion Criteria: Patients diagnosed and treated for systemic disease Pregnant and Lactating women Smokers History of allergy to statin group or patients on systemic statin therapy. History of antibiotic or periodontal therapy for the past 6 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Etika Rathi, MDS
    Organizational Affiliation
    Kamineni Institute of Dental Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23030241
    Citation
    Pradeep AR, Kumari M, Rao NS, Martande SS, Naik SB. Clinical efficacy of subgingivally delivered 1.2% atorvastatin in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2013 Jul;84(7):871-9. doi: 10.1902/jop.2012.120393. Epub 2012 Oct 2.
    Results Reference
    background

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    Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

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