Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

Study Overview
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Brief Summary
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Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.

Official Title
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Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial

Conditions
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Simvastatin, Photodynamic Therapy, Periodontal Diseases

Intervention / Treatment
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* Procedure: SMV and antimicrobial photodynamic therapy
* Procedure: SMV application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were all healthy and free from any systemic disease; no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study; patients were willing and able to return for multiple follow-up visits; good levels of oral hygiene Exclusion Criteria: Pregnant and lactating female patients, smokers, alcoholics, those receiving any medication that could affect healing of soft or hard tissue

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 |
| --- | --- |
| Experimental: SMV and antimicrobial photodynamic therapy<br>Application SMV and antimicrobial photodynamic therapy in intrabony defect | Procedure: SMV and antimicrobial photodynamic therapy<br>* Application of SMV and antimicrobial photodynamic therapy in intrabony defects<br>|
| Active Comparator: SMV application<br>Application SMV in intrabony defect | Procedure: SMV application<br>* Application of SMV without antimicrobial photodynamic therapy in intrabony defects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation and measurements of the defect in millimeters | Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters | 9 months | 
| Radiographic evaluation and measurements of the defect in millimeters | Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters | 9 months |