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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2022

Interventions

  • Procedure: L-PRF with antimicrobial photodynamic therapy
    • Application of L-PRF with antimicrobial photodynamic therapy in the defect
  • Procedure: antimicrobial photodynamic therapy without L-PRF
    • application of antimicrobial photodynamic therapy without L-PRF in the defect

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kafrelsheikh University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dalia Rasheed Issa, principle investigator – Kafrelsheikh University
  • Overall Official(s)
    • Dalia R Issa, PhD, Principal Investigator, Kafrelsheikh University
  • Overall Contact(s)
    • Dalia R Issa, PhD, 01007753636, dalia_rasheed@hotmail.com

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