NCT04823572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

March 4, 2021

Last Update Submit

April 23, 2024

Conditions

Periodontal Diseases

Keywords

Intrabony DefectsPeriodontal RegenerationA-PRFAdvanced Platelet-Rich FibrinOpen Flap Debridement

Outcome Measures

Primary Outcomes (1)

  • 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).

    Change from baseline after 6 month and after 12 month

Study Arms (2)

A-PRF Advanced Platelet-Rich Fibrin

ACTIVE COMPARATOR

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

Procedure: A-PRF/OFD

OFD Open Flap Debridement

ACTIVE COMPARATOR

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

Procedure: A-PRF/OFD

Interventions

A-PRF/OFDPROCEDURE

Comparing healing effect of an autologous and open flap debridement

A-PRF Advanced Platelet-Rich FibrinOFD Open Flap Debridement

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • systemic diseases that could influence the outcome of the therapy
  • poor oral hygiene
  • smoking
  • horizontal bone loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University, Department of Periodontology

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Dőri Ferenc, Professor

    Semmelweis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

April 1, 2021

Study Start

February 1, 2020

Primary Completion

September 30, 2022

Study Completion

February 28, 2024

Last Updated

April 24, 2024

Record last verified: 2022-04

Locations

HU(1)