Role of Simvastatin Microsponges in Treatment of Periodontitis

Study Overview
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Brief Summary
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the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.

Detailed Description
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Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.

Official Title
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Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: open flap subgingival debridement
* Procedure: Subgingival injection of chitosan 2% gel
* Procedure: Subgingival injection of chitosan 2% gel
* Procedure: Subgingival injection of chitosan 2% gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with chronic periodontitis with minimum two sites of pocket depth > 5 mm patients with normal lipid profile nonsmokers patients free from any systemic disorders committed patients to complete the treatment with follow-ups. Exclusion Criteria: patients with hyperlipidemia patients taking lipid lowering drugs smokers pregnant Lactating women women, patients with mental or psychological illness and medically compromised patients.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Plain chitosan gel group<br>After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel . | Procedure: open flap subgingival debridement<br>* After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors.<br>Procedure: Subgingival injection of chitosan 2% gel<br>* Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly<br>|
| Active Comparator: Chitosan gels containing free Simvastatin<br>Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. . | Procedure: open flap subgingival debridement<br>* After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors.<br>Procedure: Subgingival injection of chitosan 2% gel<br>* Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly<br>|
| Experimental: Chitosan gels containing Simvastatin microsponges<br>This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing . | Procedure: open flap subgingival debridement<br>* After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors.<br>Procedure: Subgingival injection of chitosan 2% gel<br>* Group (III); injected subgingivally with placebo chitosan 2% gel weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket depth | Will be measured in millimetre | Before the beginning of study | 
| Pocket depth | Will be measured in millimetre | By the end of study after 6 months of 6 months | 
| Clinical attachment loss | Will be measured in millimetre | Before beginning of the study | 
| Clinical attachment loss | Will be measured in millimetre | By the end of study after 6 months of 6 months |