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Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02600520
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: SRP with RSV gel LDD Drug: SRP with ATV gel LDD Drug: SRP with placebo gel LDD Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rosuvastatin Group
SRP followed by RSV gel LDD
Drug: SRP with RSV gel LDD
After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket

Active Comparator: Atorvastatin Group
SRP followed by ATV gel LDD
Drug: SRP with ATV gel LDD
After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket

Placebo Comparator: Placebo group
SRP followed by placebo gel LDD
Drug: SRP with placebo gel LDD
After SRP, placebo gel was delivered subgingivally into the pocket




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Dr. A R Pradeep, Professor & Head, Department of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02600520     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014X
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Atorvastatin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors