Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

NCT ID: NCT05031923

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-16

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Simvastatin Photodynamic Therapy Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SMV and antimicrobial photodynamic therapy

Application SMV and antimicrobial photodynamic therapy in intrabony defect

Group Type EXPERIMENTAL

SMV and antimicrobial photodynamic therapy

Intervention Type PROCEDURE

Application of SMV and antimicrobial photodynamic therapy in intrabony defects

SMV application

Application SMV in intrabony defect

Group Type ACTIVE_COMPARATOR

SMV application

Intervention Type PROCEDURE

Application of SMV without antimicrobial photodynamic therapy in intrabony defects

Interventions

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SMV and antimicrobial photodynamic therapy

Application of SMV and antimicrobial photodynamic therapy in intrabony defects

Intervention Type PROCEDURE

SMV application

Application of SMV without antimicrobial photodynamic therapy in intrabony defects

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Rasheed Issa

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia R Issa, PhD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

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Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dalia R Issa, PhD

Role: CONTACT

01007753636 ext. 002

Facility Contacts

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Dalia R Issa, PhD

Role: primary

01007753636 ext. 002

Other Identifiers

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waiting..

Identifier Type: -

Identifier Source: org_study_id

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