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

NCT05043935 | Recruiting

• 1 other identifier: waiting
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

L-PRF; Photodynamic Therapy; Aggressive Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

L-PRF with antimicrobial photodynamic therapy

EXPERIMENTAL

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

Procedure: L-PRF with antimicrobial photodynamic therapy

antimicrobial photodynamic therapy

ACTIVE COMPARATOR

Application antimicrobial photodynamic therapy in the defect

Procedure: antimicrobial photodynamic therapy without L-PRF

Interventions

L-PRF with antimicrobial photodynamic therapy PROCEDURE

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

L-PRF with antimicrobial photodynamic therapy

antimicrobial photodynamic therapy without L-PRF PROCEDURE

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

antimicrobial photodynamic therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

RECRUITING

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dalia R Issa, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia R Issa, PhD

CONTACT

01007753636; dalia_rasheed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 14, 2021
• Study Start: November 22, 2021
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

EG (1)