1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

Study Overview
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Brief Summary
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Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis. Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.

Official Title
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COMPARATIVE EVALUATION OF CLINICAL EFFICACY OF SUBGINGIVALLY DELIVERED 1.2% ATORVASTATIN AND 1.2% SIMVASTATIN IN TREATMENT OF CHRONIC PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: 1.2% Atorvastatin local drug delivery
* Drug: 1.2% simvastatin local drug delivery
* Drug: Placebo local drug delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months Exclusion Criteria: Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>1.2% atorvastatin local drug delivery | Drug: 1.2% Atorvastatin local drug delivery<br> <br> |
| Sham Comparator: Simvastatin<br>1.2% simvastatin local drug delivery | Drug: 1.2% simvastatin local drug delivery<br> <br> |
| Placebo Comparator: Placebo<br>Placebo local drug delivery | Drug: Placebo local drug delivery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Radiographic intra-bony defect depth. | The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect. | 9 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Probing depth. | Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months. | 9 months from baseline | 
| Change in Relative attachment level | Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months. | 9 months from baseline | 
| Change in mSBI (gingival index) | modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure. | 9 months from baseline | 
| Change in plaque index | Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable. | 9 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic periodontitis, Local drug delivery,