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RecruitingNCT05043935Updated Apr 11, 2024

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

An interventional study of L-PRF with antimicrobial photodynamic therapy and antimicrobial photodynamic therapy without L-PRF in L-PRF, Photodynamic Therapy and Aggressive Periodontitis, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • L-PRF
  • Photodynamic Therapy
  • Aggressive Periodontitis
03

In context

Aggressive Periodontitis

63 studies on the registry are indexed under Aggressive Periodontitis; 5 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 41 interventional studies indexed under Aggressive Periodontitis.

Browse Aggressive Periodontitis studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • Active comparator
    antimicrobial photodynamic therapy

    Application antimicrobial photodynamic therapy in the defect

    Procedure: antimicrobial photodynamic therapy without L-PRF

Interventions

  • ProcedureL-PRF with antimicrobial photodynamic therapy

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

  • Procedureantimicrobial photodynamic therapy without L-PRF

    application of antimicrobial photodynamic therapy without L-PRF in the defect

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 9 months

  2. 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

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05043935
Responsible party
Dalia Rasheed Issa (principle investigator, Kafrelsheikh University) — Principal investigator
First posted
Sep 14, 2021
Start date
Nov 22, 2021
Primary completion
Sep 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Apr 11, 2024

Study contacts

Dalia R Issa, PhD
Contact
dalia_rasheed@hotmail.com
01007753636 ext. 002
Dalia R Issa, PhD
principal investigator · Kafrelsheikh University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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