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Completed

NCT Number: NCT02600520

Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Background: Rosuvastatin (RSV) and Atorvastatin (ATV) 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 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).

Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemically healthy patients with PD ≥5mm or CA loss ≥4mm 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 statin group;
  • on systemic statin therapy;
  • with aggressive periodontitis;
  • who used tobacco in any form;
  • alcoholics;
  • immunocompromised patients;
  • pregnant or lactating females were excluded from the study

Treatment and study plan

SRP with RSV gel LDD

Drug

After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket

SRP with ATV gel LDD

Drug

After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket

SRP with placebo gel LDD

Drug

After SRP, placebo gel was delivered subgingivally into the pocket

Primary outcomes

  1. Change in intrabony defect depth from baseline to 6 months

    Time frame: Baseline to 6 months

    Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured

Secondary outcomes

  1. Change in plaque index (PI) from baseline to 6 months

    Time frame: Baseline to 6 months

    Reduction in plaque index (PI) from baseline to 6 months wiil be measured

  2. Change in modified sulcus bleeding index (mSBI) from baseline to 6 months

    Time frame: Baseline to 6 months

    Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured

  3. Change in probing depth (PD) from baseline to 6 months

    Time frame: Baseline to 6 months

    Reduction in probing depth (PD) from baseline to 6 months wiil be measured

  4. Change in clinical attachment (CA) level from baseline to 6 months

    Time frame: Baseline to 6 months

    Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 9, 2015
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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