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This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.
Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.
Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software
Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group.
Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months. |
|
| 1% Metformin | Active Comparator | 1% metformin gel to be delivered at baseline, 3, 6 and 9 months. |
|
| 1.2% Simvastatin | Active Comparator | 1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel | Drug | Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in defect depth reduction from baseline to 6 months and from baseline to 9 months | Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval. | Baseline to 6 months and Baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index will be measured at 3, 6 and 9 months | 3,6 and 9 months | |
| Modified sulcular bleeding index at 3, 6 and 9 months | 3 , 6 and 9 months | |
| Probing pocket depth at 3, 6 and 9 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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| ID | Term |
|---|---|
| D008687 | Metformin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D008148 |
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| 1% Metformin | Drug | 1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months. |
|
|
| 1.2% Simvastatin | Drug | 1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months. |
|
|
| 3 , 6 and 9 months |
| Clinical attachment level at 3, 6 and 9 months | 3 , 6 and 9 months |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |