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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05043935
Other study ID # waiting
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 22, 2021
Est. completion date October 2024

Study information

Verified date April 2024
Source Kafrelsheikh University
Contact Dalia R Issa, PhD
Phone 01007753636
Email dalia_rasheed@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Egypt Faculty of Dentistry, Kafrelsheikh University Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 9 months
Primary 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 9 months
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