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

April 9, 2024 updated by: Dalia Rasheed Issa, Kafrelsheikh University

The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis Patients: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Kafr Ash Shaykh, Egypt, 33511
        • Recruiting
        • faculty of dentistry, kafrelsheikh University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-PRF with antimicrobial photodynamic therapy
Application of L-PRF with antimicrobial photodynamic therapy in the defect
Procedure: L-PRF with antimicrobial photodynamic therapy
Application of L-PRF with antimicrobial photodynamic therapy in the defect
Active Comparator: antimicrobial photodynamic therapy
Application antimicrobial photodynamic therapy in the defect
Procedure: antimicrobial photodynamic therapy without L-PRF
application of antimicrobial photodynamic therapy without L-PRF in the defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation and measurements of the defect in millimeters
Time Frame: 9 months
Changes in clinical measurements in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF
9 months
Radiographic evaluation and measurements of the defect in millimeters
Time Frame: 9 months
Changes in bone formation in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Investigators

  • Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • waiting

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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