Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

NCT05031923 | Recruiting

• 1 other identifier: waiting..
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Simvastatin; Photodynamic Therapy; Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

SMV and antimicrobial photodynamic therapy

EXPERIMENTAL

Application SMV and antimicrobial photodynamic therapy in intrabony defect

Procedure: SMV and antimicrobial photodynamic therapy

SMV application

ACTIVE COMPARATOR

Application SMV in intrabony defect

Procedure: SMV application

Interventions

SMV and antimicrobial photodynamic therapy PROCEDURE

Application of SMV and antimicrobial photodynamic therapy in intrabony defects

SMV and antimicrobial photodynamic therapy

SMV application PROCEDURE

Application of SMV without antimicrobial photodynamic therapy in intrabony defects

SMV application

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant and lactating female patients,
• smokers,
• alcoholics,
• those receiving any medication that could affect healing of soft or hard tissue

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dalia R Issa, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia R Issa, PhD

CONTACT

01007753636; dalia_rasheed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 2, 2021
• Study Start: October 16, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

EG (1)