Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

January 3, 2017 updated by: ETIKA RATHI, Kamineni Institute of Dental Sciences

"Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects" - A Clinico Radiological Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: DFDBA
13 intrabony defects in chronic periodontitis patients were treated with DFDBA
Biological: DFDBA
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)
Other Names:
  • Allograft
ACTIVE_COMPARATOR: DFDBA with Atorvastatin
13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.
Drug: DFDBA with atorvastatin
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
Other Names:
  • atorvastatin gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone fill in mm was measured by taking radiographs
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamineni Institute of Dental Sciences

Investigators

  • Principal Investigator: Etika Rathi, MDS, Kamineni Institute of Dental Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (ESTIMATE)

January 4, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kamineni perio

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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