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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin Group | Active Comparator | SRP followed by RSV gel LDD |
|
| Atorvastatin Group | Active Comparator | SRP followed by ATV gel LDD |
|
| Placebo group | Placebo Comparator | SRP followed by placebo gel LDD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP with RSV gel LDD | Drug | After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plaque index (PI) from baseline to 6 months | Reduction in plaque index (PI) from baseline to 6 months wiil be measured | Baseline to 6 months |
| Change in modified sulcus bleeding index (mSBI) from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
|
Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured
| 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 | 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 | Baseline to 6 months |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |