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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
After SRP, placebo gel was delivered subgingivally into the pocket
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
Time frame: Baseline to 6 months
Change in plaque index (PI) from baseline to 6 months
Reduction in plaque index (PI) from baseline to 6 months wiil be measured
Time frame: Baseline to 6 months
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
Time frame: Baseline to 6 months
Change in probing depth (PD) from baseline to 6 months
Reduction in probing depth (PD) from baseline to 6 months wiil be measured
Time frame: Baseline to 6 months
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
Time frame: Baseline to 6 months
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