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The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis

Primary Purpose

L-PRF, Photodynamic Therapy, Aggressive Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
L-PRF with antimicrobial photodynamic therapy
antimicrobial photodynamic therapy without L-PRF
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for L-PRF

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • systemically healthy
  • non- smoker,
  • not received any periodontal treatment within the last 6 months,
  • no antibiotics, anti- inflammatory drugs or any other medication taken within the last 6 months

Exclusion Criteria:

  • any systemic disease that might influence the prognosis of periodontal disease and outcome of the treatment,
  • any medical condition that required antibiotic prophylaxis before the treatment,
  • smoking,
  • pregnancy and lactation,
  • ingestion of antibiotics, anti-inflammatory drugs or any other medication during the study period,
  • any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Sites / Locations

  • Faculty of Dentistry, Kafrelsheikh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-PRF with antimicrobial photodynamic therapy

antimicrobial photodynamic therapy

Arm Description

Application of L-PRF with antimicrobial photodynamic therapy in the defect

Application antimicrobial photodynamic therapy in the defect

Outcomes

Primary Outcome Measures

Clinical evaluation and measurements of the defect in millimeters
Changes in clinical measurements in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF
Radiographic evaluation and measurements of the defect in millimeters
Changes in bone formation in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF

Secondary Outcome Measures

Full Information

First Posted
August 20, 2021
Last Updated
September 5, 2021
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT05043935
Brief Title
The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis
Official Title
The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis Patients: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
October 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 associated with photosensitizing agents which promote the generation of free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Leukocyte and platelet-rich fibrin (L-PRF) has been used extensively in the treatment of intrabony defects and achieved excellent results. It acts as an immune regulation node with inflammation control abilities, including a slow continuous release of growth factors which stimulates periodontal regeneration. The aim of this study is to evaluate the adjunctive effects of aPDT with and without L-PRF in aggressive periodontitis patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
L-PRF, Photodynamic Therapy, Aggressive Periodontitis

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: systemically healthy non- smoker, not received any periodontal treatment within the last 6 months, no antibiotics, anti- inflammatory drugs or any other medication taken within the last 6 months Exclusion Criteria: any systemic disease that might influence the prognosis of periodontal disease and outcome of the treatment, any medical condition that required antibiotic prophylaxis before the treatment, smoking, pregnancy and lactation, ingestion of antibiotics, anti-inflammatory drugs or any other medication during the study period, any physical limitations or restrictions that might preclude normal oral hygiene procedures.
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

The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis

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