Treatment of Periodontal Intrabony Defects With A-PRF or OFD

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823572
• Other study ID #: SE TUKEB 254/2017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2022
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Procedure:
• A-PRF/OFD
Comparing healing effect of an autologous and open flap debridement

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Periodontology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal clinical parameters	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