1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis

Study Overview
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Brief Summary
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The purpose of the present study was to evaluate the effects of subgingival delivery of Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic Periodontitis (CP) patients.

Detailed Description
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Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome this, various systemic and local drug delivered antimicrobials have been used as an adjunct to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2% rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic periodontitis (CP). Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at baseline, 6 and 9 months.

Official Title
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1.2% Rosuvastatin Gel As A Local Drug Delivery Agent In Smokers With Chronic Periodontitis- A Randomized Controlled Clinical Trial.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: SRP plus Rosuvastatin gel
* Drug: SRP plus placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy CP subjects aged between 30-50 years who are current smokers with no history of periodontal therapy or use of antibiotics in past 6 months, having sites with intrabony defect depth (IBD) ≥ 3mm (distance between alveolar crest and base of the defect on intraoral periapical radiograph) along with PPD ≥5 mm or CAL ≥3 mm in an asymptomatic tooth were included in the study. A subject was considered as a current smoker if he regularly smoked more than 10 cigarettes/day for a minimum of 5 years Exclusion Criteria: Former smokers, i.e. subjects who had previously been smokers but stopped their habit, and non-smokers were excluded. Subjects allergic to statins, on systemic statin therapy, with any known systemic disease or any other systemic inflammation/ infection which could alter the course of periodontal disease and users of tobacco in any other form than cigarettes were excluded from the study

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin Group<br>Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects | Drug: SRP plus Rosuvastatin gel<br>* SRP followed by Rosuvastatin placement into intrabony defect<br>|
| Placebo Comparator: Placebo Group<br>Oral prophylaxis followed by placebo gel placement in intrabony defects | Drug: SRP plus placebo gel<br>* SRP followed by placebo gel placement into intrabony defect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defect depth reduction (%) | assessed in percentage | Change from baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth (mm) | measured in mm | Change from baseline to 9 months | 
| clinical attachment level (mm) | measured in mm | Change from baseline to 9 months | 
| modified sulcus bleeding index | scale from 0-3 | Change from baseline to 9 months | 
| Plaque Index | scale from 0-3 | Change from baseline to 9 months |