Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: A-PRF/EMD

• Registration Number: NCT04404374
• Lead Sponsor: Semmelweis University

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.

Study Timeline

• Study Start: 2018-06-27
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-PRF	A-PRF/EMD	Advanced Platelet-Rich Fibrin
EMD	A-PRF/EMD	Enamel Matrix Derivatives

Primary Outcome Measures

Name	Time	Method
Periodontal clinical parameters - to determine the clinical attachment level (CAL)	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	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).

Trial Locations

Locations (1)

Semmelweis University, Department of Periodontology; 🇭🇺 Budapest, Hungary