Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD

NCT ID: NCT04404374

Last Updated: 2021-03-05

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

2018-06-27

Study Completion Date

2020-12-31

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+) to enamel matrix derivatives (EMD) in periodontitis patients.

Detailed Description

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Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled with A-PRF+ (n=15) in the test group, respectively with EMD 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

Group Type ACTIVE_COMPARATOR

A-PRF/EMD

Intervention Type PROCEDURE

Comparing healing effect of an autologous and a xenogenic product

EMD

Enamel Matrix Derivatives

Group Type ACTIVE_COMPARATOR

A-PRF/EMD

Intervention Type PROCEDURE

Comparing healing effect of an autologous and a xenogenic product

Interventions

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A-PRF/EMD

Comparing healing effect of an autologous and a xenogenic product

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* no systemic diseases that could influence the outcome of the therapy, a good level of oral hygiene, he 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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Boroka Csifo-Nagy

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ferenc Dr.Dőri, professor

Role: STUDY_DIRECTOR

Semmelweis University

Locations

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Semmelweis University, Department of Periodontology

Budapest, , Hungary

Site Status

Countries

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Hungary

References

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Csifo-Nagy BK, Solyom E, Bognar VL, Nevelits A, Dori F. Efficacy of a new-generation platelet-rich fibrin in the treatment of periodontal intrabony defects: a randomized clinical trial. BMC Oral Health. 2021 Nov 15;21(1):580. doi: 10.1186/s12903-021-01925-1.

Reference Type DERIVED
PMID: 34781955 (View on PubMed)

Other Identifiers

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SE TUKEB: 254/2017

Identifier Type: -

Identifier Source: org_study_id

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