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Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

Primary Purpose

Simvastatin, Photodynamic Therapy, Periodontal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SMV and antimicrobial photodynamic therapy
SMV application
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Simvastatin

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry, Kafrelsheikh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SMV and antimicrobial photodynamic therapy

SMV application

Arm Description

Application SMV and antimicrobial photodynamic therapy in intrabony defect

Application SMV in intrabony defect

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2021
Last Updated
August 26, 2021
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT05031923
Brief Title
Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy
Official Title
Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Simvastatin, Photodynamic Therapy, Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SMV and antimicrobial photodynamic therapy
Arm Type
Experimental
Arm Description
Application SMV and antimicrobial photodynamic therapy in intrabony defect
Arm Title
SMV application
Arm Type
Active Comparator
Arm Description
Application SMV in intrabony defect
Intervention Type
Procedure
Intervention Name(s)
SMV and antimicrobial photodynamic therapy
Intervention Description
Application of SMV and antimicrobial photodynamic therapy in intrabony defects
Intervention Type
Procedure
Intervention Name(s)
SMV application
Intervention Description
Application of SMV without antimicrobial photodynamic therapy in intrabony defects
Primary Outcome Measure Information:
Title
Clinical evaluation and measurements of the defect in millimeters
Description
Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Time Frame
9 months
Title
Radiographic evaluation and measurements of the defect in millimeters
Description
Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia R Issa, PhD
Phone
01007753636
Ext
002
Email
dalia_rasheed@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia R Issa, PhD
Organizational Affiliation
Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Kafrelsheikh University
City
Kafr Ash Shaykh
ZIP/Postal Code
33511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalia R Issa, PhD
Phone
01007753636
Ext
002
Email
dalia_rasheed@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

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