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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05031923
Other study ID # waiting..
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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