Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD

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+) 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.

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

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Procedure: A-PRF/EMD


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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<br>Advanced Platelet-Rich Fibrin | Procedure: A-PRF/EMD<br>* Comparing healing effect of an autologous and a xenogenic product<br>|
| Active Comparator: EMD<br>Enamel Matrix Derivatives | Procedure: A-PRF/EMD<br>* Comparing healing effect of an autologous and a xenogenic product<br>|

What is the study measuring?
-----------------
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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EMD, Intrabony Defects, New-Generation Platelet-Rich Fibrin, Enamel Matrix Derivatives, Periodontal Regeneration, A-PRF+, Advanced Platelet-Rich Fibrin