Efficacy of a New-generation Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Semmelweis University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Periodontal clinical parameters
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •horizontal bone loss
Arms & Interventions
A-PRF Advanced Platelet-Rich Fibrin
Comparing healing effect of an autologous product with open flap debridement.
Intervention: A-PRF/OFD (Procedure)
OFD Open Flap Debridement
Comparing healing effect of an autologous product with open flap debridement.
Intervention: A-PRF/OFD (Procedure)
Outcomes
Primary Outcomes
Periodontal clinical parameters
Time Frame: Change from baseline after 6 month and after 12 month
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).
Secondary Outcomes
No secondary outcomes reported