Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis

June 14, 2016 updated by: Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Comparative Evaluation of Locally Delivered 1.2% Atorvastatin and 1.2% Rosuvastatin Gel in Treatment of Mandibular Degree ii Furcation Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial

Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Study Overview

Status

Completed

Detailed Description

Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Government Dental College and Research Institute

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

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study

Exclusion Criteria:

  • Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group 1
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Oral prophylaxis followed by placement of placebo gel
Other Names:
  • inactive drug
Active Comparator: group 2
SRP followed by 1.2% rosuvastatin (RSV) gel
Oral prophylaxis followed by placement of rosuvastatin gel
Other Names:
  • RSV
Active Comparator: group 3
SRP followed by 1.2% Atorvastatin (ATV) gel
Oral prophylaxis followed by placement of atorvastatin gel
Other Names:
  • ATV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bone defect fill
Time Frame: baseline, 6 & 9 months
Assessed in percentage
baseline, 6 & 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in modified sulcus bleeding index
Time Frame: baseline, 6 & 9 months
scale 0-3
baseline, 6 & 9 months
Change in Plaque index
Time Frame: baseline, 6 & 9 months
scale 0-3
baseline, 6 & 9 months
Change in pocket probing depth
Time Frame: baseline, 6 & 9 months
measured in mm
baseline, 6 & 9 months
Change in relative vertical clinical attachment level
Time Frame: baseline, 6 & 9 months
measured in mm
baseline, 6 & 9 months
Change in relative horizontal clinical attachment level
Time Frame: baseline, 6 & 9 months
measured in mm
baseline, 6 & 9 months

Collaborators and Investigators

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

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.

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

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

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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