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The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
Background: Alendronate and Atorvastatin 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% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket |
|
| Atorvastatin group | Active Comparator | SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally |
|
| Alendronate Group | Active Comparator | Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP and Placebo gel | Drug | After SRP, placebo gel was delivered subgingivally into the pocket |
|
| 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 | Plaque index will be measured at 3, 6 and 9 months | 3,6 and 9 months |
| Modified sulcus bleeding index | Modified sulcus bleeding index will be measured 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 |
|---|---|
| D000069059 | Atorvastatin |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| SRP and Atorvastatin | Drug | After SRP, Atorvastatin gel was delivered subgingivally into the pocket |
|
| SRP and Alendronate | Drug | After SRP, Alendronate gel was delivered subgingivally into the pocket |
|
| 3,6 and 9 months] |
| Probing pocket depth | Probing pocket depth will be measured at 3, 6 and 9 months | 3,6 and 9 months] |
| Clinical attachment level | Clinical attachment level will be measured 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 |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |