Treatment of Periodontal Intrabony Defects With A-PRF or OFD

Not Applicable

Completed

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

• Registration Number: NCT04823572
• 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+) 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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-27
• Study First Posted: 2021-04-01
• Status Verified: 2022-04
• Primary Completion: 2022-09-30
• Study Completion: 2024-02-28
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OFD Open Flap Debridement	A-PRF/OFD	Comparing healing effect of an autologous product with open flap debridement.
A-PRF Advanced Platelet-Rich Fibrin	A-PRF/OFD	Comparing healing effect of an autologous product with open flap debridement.

Primary Outcome Measures

Name	Time	Method
Periodontal clinical parameters	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).

Trial Locations

Locations (1)

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