Treatment of Periodontal Intrabony Defects With A-PRF or OFD

Study Overview
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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+) toped flap debridement (OFD) in periodontitis patients.

Detailed Description
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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.

Official Title
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Efficacy of a New-generation Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: A-PRF/OFD


Participation Criteria
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Eligibility Criteria
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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 smoking horizontal bone loss

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A-PRF Advanced Platelet-Rich Fibrin<br>Comparing healing effect of an autologous product with open flap debridement. | Procedure: A-PRF/OFD<br>* Comparing healing effect of an autologous and open flap debridement<br>|
| Active Comparator: OFD Open Flap Debridement<br>Comparing healing effect of an autologous product with open flap debridement. | Procedure: A-PRF/OFD<br>* Comparing healing effect of an autologous and open flap debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrabony Defects, Periodontal Regeneration, A-PRF, Advanced Platelet-Rich Fibrin, Open Flap Debridement