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Clinical Trials/NCT04823572
NCT04823572
Completed
Not Applicable

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

Semmelweis University1 site in 1 country30 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Diseases
Sponsor
Semmelweis University
Enrollment
30
Locations
1
Primary Endpoint
Periodontal clinical parameters
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
February 28, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • horizontal bone loss

Outcomes

Primary Outcomes

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).

Study Sites (1)

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