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Completed

NCT Number: NCT04823572

Treatment of Periodontal Intrabony Defects With A-PRF or OFD

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Department of Periodontology

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A-PRF/OFD

Procedure

Comparing healing effect of an autologous and open flap debridement

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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