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Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP 1 | Active Comparator | Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery |
|
| GROUP 2 | Active Comparator | Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery |
|
| GROUP 3 | Placebo Comparator | Scaling and root planing (SRP) followed by placebo gel local drug delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATORVASTATIN | Drug | Scaling and Root Planing (SRP) followed by placement of atorvastatin gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in defect depth | assessed in percentage | 6 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in probing depth (PD) | baseline, 6 and 9 months | |
| change in Clinical Attachment Level (CAL) | baseline, 6 and 9 months | |
| CHANGE IN Plaque Index (PI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avani R Pradeep, MDS | GDCRI, Bangalore, INDIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontics, GDCRI Bangalore | Bangalore | Karnataka | 560002 | India |
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| SIMVASTATIN | Drug | Scaling and Root Planing (SRP) followed by placement of simvastatin gel |
|
|
| PLACEBO | Drug | Scaling and Root Planing (SRP) followed by placement of placebo gel |
|
|
| baseline, 6 and 9 months |
| change in modified Sulcus Bleding Index (mSBI) | baseline, 6 and 9 months |
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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