Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

Overview

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.

Full Title of Study: “Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: August 2022

Interventions

• Procedure: SMV and antimicrobial photodynamic therapy
  • Application of SMV and antimicrobial photodynamic therapy in intrabony defects
• Procedure: SMV application
  • Application of SMV without antimicrobial photodynamic therapy in intrabony defects

Arms, Groups and Cohorts

• Experimental: SMV and antimicrobial photodynamic therapy
  • Application SMV and antimicrobial photodynamic therapy in intrabony defect
• Active Comparator: SMV application
  • Application SMV in intrabony defect

Clinical Trial Outcome Measures

Primary Measures

• Clinical evaluation and measurements of the defect in millimeters
  • Time Frame: 9 months
  • Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
• Radiographic evaluation and measurements of the defect in millimeters
  • Time Frame: 9 months
  • Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Kafrelsheikh University
• Provider of Information About this Clinical Study
  • Principal Investigator: Dalia Rasheed Issa, Principle investigator – Kafrelsheikh University
• Overall Official(s)
  • Dalia R Issa, PhD, Principal Investigator, Kafrelsheikh University
• Overall Contact(s)
  • Dalia R Issa, PhD, 01007753636, dalia_rasheed@hotmail.com