The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis

Study Overview
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Brief Summary
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To assess the effectiveness of advanced PRF+ as compared to open flap debridement in treatment of periodontal intraosseous defects in stage III periodontitis patients.

Detailed Description
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The application of platelet concentrates characterized by high concentrations of platelets and growth factors have been applied and investigated as possible periodontal regenerative therapy. The application of platelet rich fibrin in management of intraosseous and furcation defects produce more favorable outcome compared to open flap debridement. A-PRF+ represents the latest generation of platelet concentrates that could provide sustained and increased release of growth factors and could serve as an autologous cost-effective membrane in periodontal tissue regeneration procedures

Official Title
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Evaluation of CAL Gain Following Treatment of Intraosseous Defects With A-PRF+ Compared to Open Flap Debridement in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Conditions
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Intrabony Periodontal Defect

Intervention / Treatment
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* Procedure: Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD)
* Procedure: Open flap debridement (OFD) alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm. Defect not extending to a root furcation area Non-smokers. No history of intake of medications affecting the periodontium in the previous 6 months. Able to sign an informed consent form. Patients age between 18 and 60 years old. Patients who are cooperative, motivated, and hygiene conscious. Systemically free according to Cornell Medical Index (Broadbent, 1951). Exclusion Criteria: Pregnancy or breast feeding The presence of an orthodontic appliance Teeth mobility greater than grade I

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced- platelets rich fibrin plus with open flap debridement<br>Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, A-PRF+ of the required size will be filled into the intraosseous defect, the mucoperiosteal flaps will be repositioned and secured in place using 4-0 silk sutures | Procedure: Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD)<br>* Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , A-PRF+ of the required size will be filled into the intraosseous defect. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures<br>|
| Active Comparator: Open flap debridement (OFD)<br>Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, The interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps. | Procedure: Open flap debridement (OFD) alone<br>* Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded. After debridement and intraoperative recordings, interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Level (CAL) gain | Clinical Attachment Level (CAL) will be measured from the cemento enamel junction (CEJ) to the bottom of the gingival sulcus/periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth | Change from Baseline Clinical Attachment Level (CAL) at 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth (PD) | Probing Depth (PD) will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth | Probing Depth will be measured at base line,3,6, and 9 months postoperative | 
| Radiographic defect fill | The depth of intrabony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiographs. Radiographs will be scanned and the radiographic (intrabony defect) IBD depth was measured by a computer-aided software program | Radiographic defect fill will be measured at 6,9,months | 
| Gingival Recession Depth (RD) | Gingival Recession Depth (RD) will be measured from the cemento enamel junction (CEJ) to the most apical extension of the gingival margin using University of North Carolina (UNC) periodontal probe at six sites per tooth | Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage 3 periodontitis, A-PRF, Advanced platelet rich fibrin, open flap debridement, OFD, 2-wall intraosseous defect, 3-wall intraosseous defect