Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031923
• Other study ID #: waiting..
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2021
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Kafrelsheikh University
• Contact: Dalia R Issa, PhD
• Phone: 01007753636
• Email: dalia_rasheed[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases
• Photodynamic Therapy

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Kafrelsheikh University	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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