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Treatment of Periodontal Intrabony Defects With A-PRF or OFD

Primary Purpose

Periodontal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
A-PRF/OFD
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Intrabony Defects, Periodontal Regeneration, A-PRF, Advanced Platelet-Rich Fibrin, Open Flap Debridement

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Semmelweis University, Department of PeriodontologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A-PRF Advanced Platelet-Rich Fibrin

OFD Open Flap Debridement

Arm Description

Comparing healing effect of an autologous product with open flap debridement.

Comparing healing effect of an autologous product with open flap debridement.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 4, 2021
Last Updated
May 10, 2022
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT04823572
Brief Title
Treatment of Periodontal Intrabony Defects With A-PRF or OFD
Official Title
Efficacy of a New-generation Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Intrabony Defects, Periodontal Regeneration, A-PRF, Advanced Platelet-Rich Fibrin, Open Flap Debridement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A-PRF Advanced Platelet-Rich Fibrin
Arm Type
Active Comparator
Arm Description
Comparing healing effect of an autologous product with open flap debridement.
Arm Title
OFD Open Flap Debridement
Arm Type
Active Comparator
Arm Description
Comparing healing effect of an autologous product with open flap debridement.
Intervention Type
Procedure
Intervention Name(s)
A-PRF/OFD
Intervention Description
Comparing healing effect of an autologous and open flap debridement
Primary Outcome Measure Information:
Title
Periodontal clinical parameters
Description
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).
Time Frame
Change from baseline after 6 month and after 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boróka Csifó-Nagy, Assistant Lecturer
Phone
+36307032106
Email
drcsifo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ferenc Dőri, Professor
Email
drferencdori957@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dőri Ferenc, Professor
Organizational Affiliation
Semmelweis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University, Department of Periodontology
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boróka Csifó-Nagy
Phone
0036307032106
Email
drcsifo@gmail.com
First Name & Middle Initial & Last Name & Degree
Ferenc Dőri, Professor
Email
drferencdori957@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Treatment of Periodontal Intrabony Defects With A-PRF or OFD

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