Back to resultsTreatment of Periodontal Intrabony Defects With A-PRF+ or EMD
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
A-PRF/EMD
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Intrabony Defects, New-Generation Platelet-Rich Fibrin, Enamel Matrix Derivatives, Periodontal Regeneration, EMD, A-PRF+, Advanced Platelet-Rich Fibrin
Eligibility Criteria
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
Sites / Locations
- Semmelweis University, Department of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A-PRF
EMD
Arm Description
Advanced Platelet-Rich Fibrin
Enamel Matrix Derivatives
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).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04404374
Brief Title
Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD
Official Title
Efficacy of a New-generation Platelet-rich Fibrin vs. Enamel Matrix Derivatives in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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+) to enamel matrix derivatives (EMD) in periodontitis patients.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Intrabony Defects, New-Generation Platelet-Rich Fibrin, Enamel Matrix Derivatives, Periodontal Regeneration, EMD, A-PRF+, Advanced Platelet-Rich Fibrin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A-PRF
Arm Type
Active Comparator
Arm Description
Advanced Platelet-Rich Fibrin
Arm Title
EMD
Arm Type
Active Comparator
Arm Description
Enamel Matrix Derivatives
Intervention Type
Procedure
Intervention Name(s)
A-PRF/EMD
Intervention Description
Comparing healing effect of an autologous and a xenogenic product
Primary Outcome Measure Information:
Title
Periodontal clinical parameters - to determine the clinical attachment level (CAL)
Description
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).
Time Frame
Change from baseline after 6 month and after 12 month
Title
Periodontal clinical parameters
Description
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).
Time Frame
Change from baseline after 6 month and after 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferenc Dr.Dőri, professor
Organizational Affiliation
Semmelweis University
Official's Role
Study Director
Facility Information:
Facility Name
Semmelweis University, Department of Periodontology
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
34781955
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD
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