Furcation Treatment With L-PRF and aPDT

June 20, 2021 updated by: Walid Elamrousy, Kafrelsheikh University

Evaluation of Leukocyte Platelet Rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Furcation Involvement: Randomised Clinical Study

To treat grade II periodontally diseased furcation areas Leukocyte-Platelet Rich Fibrin (L-PRF) combined with antimicrobial Photo-Dynamic Therapy (a-PDT) was used.

Study Overview

Status

Completed

Conditions

Detailed Description

randomized, triple-blinded study (patient, clinician and biostatistician). Twenty-four patients with Grade II furcation involvement were recruited in this study.

Control group only received L-PRF, while study group used a combination of L-PRF and aPDT Attachment level, pocket depth, horizontal component and gingival recession, also radiographic Bone depth, width, height and volume were were recorded at baseline and postoperatively after 6 months

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

      • Kafr Ash Shaykh, Egypt, 214312
        • faculty of dentistry, kafrelsheikh University

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

32 years to 48 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Grade II furcation involvement
  • age range 18- 50 years
  • 3 mm or more vertical probing depth

Exclusion Criteria:

  • systemic disease
  • abnormal clotting and bleeding
  • smokers,
  • root caries or restoration
  • Grade II mobility
  • periapical lesions

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: L-PRF
Leukocyte platelet rich fibrin as a sole graft material in class II furcation
surgical open flap debridement followed by L-PRF alone
ACTIVE_COMPARATOR: L-PRF with aPDT
Leukocyte platelet rich fibrin combined with antibacterial photodynamic therapy in class II furcation
surgical open flap debridement followed by L-PRF with aPDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of Vertical clinical attachment level VCAL
Time Frame: 6 months
using periodontal probe in mm
6 months
clinical evaluation of vertical pocket depth VPD
Time Frame: 6 months
using periodontal probe in mm
6 months
clinical evaluation of furcation horizontal component FHC
Time Frame: 6 months
using periodontal probe in mm
6 months
clinical evaluation of gingival recession REC
Time Frame: 6 months
using periodontal probe in mm
6 months

Collaborators and Investigators

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

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)

July 28, 2020

Primary Completion (ACTUAL)

April 12, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (ACTUAL)

April 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 20, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • elamrousy2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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