Periodontal Diseases Clinical Trial
Official title:
Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Kafrelsheikh University | Kafr Ash Shaykh |
Lead Sponsor | Collaborator |
---|---|
Kafrelsheikh University |
Egypt,
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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