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Clinical Trials/NCT04404374
NCT04404374
Completed
Not Applicable

Efficacy of a New-generation Platelet-rich Fibrin vs. Enamel Matrix Derivatives in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial

Semmelweis University1 site in 1 country30 target enrollmentJune 27, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Diseases
Sponsor
Semmelweis University
Enrollment
30
Locations
1
Primary Endpoint
Periodontal clinical parameters - to determine the clinical attachment level (CAL)
Status
Completed
Last Updated
5 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+) to enamel matrix derivatives (EMD) in periodontitis patients.

Detailed Description

Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed with sutures to ensure wound closure and stability.

Registry
clinicaltrials.gov
Start Date
June 27, 2018
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Boroka Csifo-Nagy

Assistant Professor

Semmelweis University

Eligibility Criteria

Inclusion Criteria

  • no systemic diseases that could influence the outcome of the therapy, a good level of oral hygiene, he 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

Outcomes

Primary Outcomes

Periodontal clinical parameters - to determine the clinical attachment level (CAL)

Time Frame: Change from baseline after 6 month and after 12 month

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).

Periodontal clinical parameters

Time Frame: Change from baseline after 6 month and after 12 month

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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