Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD
Efficacy of a New-generation Platelet-rich Fibrin vs. Enamel Matrix Derivatives in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
1 other identifier
interventional
30
1 country
1
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+) to enamel matrix derivatives (EMD) in periodontitis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2018
CompletedFirst Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 5, 2021
March 1, 2021
2 years
May 19, 2020
March 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Periodontal clinical parameters
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
ACTIVE COMPARATORAdvanced Platelet-Rich Fibrin
EMD
ACTIVE COMPARATOREnamel Matrix Derivatives
Interventions
Eligibility Criteria
You may qualify if:
- 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
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
Related Publications (1)
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.
PMID: 34781955DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ferenc Dr.Dőri, professor
Semmelweis University
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 27, 2020
Study Start
June 27, 2018
Primary Completion
June 30, 2020
Study Completion
December 31, 2020
Last Updated
March 5, 2021
Record last verified: 2021-03