Treatment of Periodontal Intrabony Defects With A-PRF or OFD

April 23, 2024 updated by: Semmelweis University

Efficacy of a New-generation Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial

The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) toped flap debridement (OFD) in periodontitis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty (30) intrabony defects are randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects are filled with A-PRF+ (n=15) in the test group, respectively treated with open flap debridement in the control group, and fixed with sutures to ensure wound closure and stability.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University, Department of Periodontology

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

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • no systemic diseases
  • a good level of oral hygiene
  • presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees
  • with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs
  • no smoking

Exclusion Criteria:

  • systemic diseases that could influence the outcome of the therapy
  • poor oral hygiene
  • smoking
  • horizontal bone loss

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A-PRF Advanced Platelet-Rich Fibrin
Comparing healing effect of an autologous product with open flap debridement.
Procedure: A-PRF/OFD
Comparing healing effect of an autologous and open flap debridement
Active Comparator: OFD Open Flap Debridement
Comparing healing effect of an autologous product with open flap debridement.
Procedure: A-PRF/OFD
Comparing healing effect of an autologous and open flap debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal clinical parameters
Time Frame: Change from baseline after 6 month and after 12 month
to determine the clinical attachment level (CAL) With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
Change from baseline after 6 month and after 12 month

Collaborators and Investigators

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

Sponsor

Semmelweis University

Investigators

  • Principal Investigator: Dőri Ferenc, Professor, Semmelweis University

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)

February 1, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 27, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE TUKEB 254/2017

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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