Treatment of Periodontal Intrabony Defects With A-PRF or OFD

NCT ID: NCT04823572

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-02-28

Brief Summary

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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

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A-PRF Advanced Platelet-Rich Fibrin

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

Group Type ACTIVE_COMPARATOR

A-PRF/OFD

Intervention Type PROCEDURE

Comparing healing effect of an autologous and open flap debridement

OFD Open Flap Debridement

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

Group Type ACTIVE_COMPARATOR

A-PRF/OFD

Intervention Type PROCEDURE

Comparing healing effect of an autologous and open flap debridement

Interventions

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A-PRF/OFD

Comparing healing effect of an autologous and open flap debridement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dőri Ferenc, Professor

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

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Semmelweis University, Department of Periodontology

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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SE TUKEB 254/2017

Identifier Type: -

Identifier Source: org_study_id

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