1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus

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 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.

Detailed Description
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Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients. Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group). At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.

Official Title
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1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial

Conditions
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Chronic Periodontitis, Type2 Diabetes

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: Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy Exclusion Criteria: Patients with any other known systemic disease Patients on systemic statin therapy Known or suspected allergy to statin supplementation Patients with aggressive periodontitis Tobacco use in any form, smokers, alcoholics Immunocompromised patients Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 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 1.2% 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 |