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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

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

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.

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

NCT ID

NCT04823572

First Posted

March 4, 2021

Last Updated

May 10, 2022

Sponsor

Semmelweis University

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

Studies a U.S. FDA-regulated Device Product

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

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

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

drcsifo@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ferenc Dőri, Professor

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

drcsifo@gmail.com

First Name & Middle Initial & Last Name & Degree

Ferenc Dőri, Professor

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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