Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases; Photodynamic Therapy; Simvastatin
• Intervention / Treatment: Procedure: SMV and antimicrobial photodynamic therapy; Procedure: SMV application

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dalia R Issa, PhD; Phone Number: 002 01007753636; Email: dalia_rasheed@hotmail.com

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 33511
    • Recruiting
    • faculty of dentistry, kafrelsheikh University
    • Contact: Dalia R Issa, PhD; Phone Number: 002 01007753636; Email: dalia_rasheed@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMV and antimicrobial photodynamic therapy; Application SMV and antimicrobial photodynamic therapy in intrabony defect	Procedure: SMV and antimicrobial photodynamic therapy; Application of SMV and antimicrobial photodynamic therapy in intrabony defects
Active Comparator: SMV application; Application SMV in intrabony defect	Procedure: SMV application; Application of SMV without antimicrobial photodynamic therapy in intrabony defects

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: waiting..

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No