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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05031923

Enrollment

Registered

2021-09-02

Start date

2021-10-16

Completion date

2024-08-31

Last updated

2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Photodynamic Therapy, Simvastatin

Brief 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.

Interventions

PROCEDURESMV and antimicrobial photodynamic therapy

Application of SMV and antimicrobial photodynamic therapy in intrabony defects

PROCEDURESMV application

Application of SMV without antimicrobial photodynamic therapy in intrabony defects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical evaluation and measurements of the defect in millimeters	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	9 months	Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters

Countries

Egypt

Contacts

Primary ContactDalia R Issa, PhD

dalia_rasheed@hotmail.com01007753636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026