Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SRP with RSV gel LDD
SRP with ATV gel LDD
SRP with placebo gel LDD
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Rosuvastatin Group
Atorvastatin Group
Placebo group
Arm Description
SRP followed by RSV gel LDD
SRP followed by ATV gel LDD
SRP followed by placebo gel LDD
Outcomes
Primary Outcome Measures
Change in intrabony defect depth from baseline to 6 months
Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured
Secondary Outcome Measures
Change in plaque index (PI) from baseline to 6 months
Reduction in plaque index (PI) from baseline to 6 months wiil be measured
Change in modified sulcus bleeding index (mSBI) from baseline to 6 months
Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured
Change in probing depth (PD) from baseline to 6 months
Reduction in probing depth (PD) from baseline to 6 months wiil be measured
Change in clinical attachment (CA) level from baseline to 6 months
Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured
Full Information
NCT ID
NCT02600520
First Posted
November 6, 2015
Last Updated
November 11, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02600520
Brief Title
Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin Group
Arm Type
Active Comparator
Arm Description
SRP followed by RSV gel LDD
Arm Title
Atorvastatin Group
Arm Type
Active Comparator
Arm Description
SRP followed by ATV gel LDD
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
SRP followed by placebo gel LDD
Intervention Type
Drug
Intervention Name(s)
SRP with RSV gel LDD
Intervention Description
After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
Intervention Type
Drug
Intervention Name(s)
SRP with ATV gel LDD
Intervention Description
After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
Intervention Type
Drug
Intervention Name(s)
SRP with placebo gel LDD
Intervention Description
After SRP, placebo gel was delivered subgingivally into the pocket
Primary Outcome Measure Information:
Title
Change in intrabony defect depth from baseline to 6 months
Description
Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in plaque index (PI) from baseline to 6 months
Description
Reduction in plaque index (PI) from baseline to 6 months wiil be measured
Time Frame
Baseline to 6 months
Title
Change in modified sulcus bleeding index (mSBI) from baseline to 6 months
Description
Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured
Time Frame
Baseline to 6 months
Title
Change in probing depth (PD) from baseline to 6 months
Description
Reduction in probing depth (PD) from baseline to 6 months wiil be measured
Time Frame
Baseline to 6 months
Title
Change in clinical attachment (CA) level from baseline to 6 months
Description
Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis
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