Clinical Effect of APRF With DFDBA Compare to Collagen Membrane With DFDBA in Intraosseous Defect

Study Overview
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Brief Summary
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to assess the effectiveness of advanced PRF in combination of Demineralized freeze-dried bone allograft (DFDBA) as compared to collagen membrane in combination with Demineralized freeze-dried bone allograft (DFDBA) treatment of non-contained periodontal intraosseous defects in stage III periodontitis patients.

Detailed Description
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Treatment of intraosseous periodontal defects represents a clinical challenge; these defects have been detected through clinical and radiographic examination in 18- 51 % of patients with periodontitis. They are often associated with persistent deep pockets and bleeding following conventional periodontal treatment. Complex regenerative periodontal therapy is advocated for management of these defects. The outcomes of regenerative periodontal therapy are positively correlated with the morphology of osseous defects. Non-contained defects are prevalent clinically and have been reported to have a low regenerative potential.

Official Title
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Clinical Evaluation of Advanced Platelet Rich Fibrin With (DFDBA) Compared to Collagen Membrane With (DFDBA) in Treatment of Non-contained Intraosseous Defects in Stage III Periodontitis Patients: 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) with Demineralized freeze-dried bone allograft (DFDBA)
* Procedure: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage III periodontitis patient having at least one tooth with one wall or combined1- to 2-wall intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm. Defect not extending to a root furcation area Vital teeth Non-smokers. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. No periodontal therapy carried out in the past 6 months. Able to sign an informed consent form. Patients age between 25 and 50 years old. Patients who are cooperative, motivated, and hygiene conscious. Systemically free according to Cornell Medical Index 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: 25 Years
Maximum Age: 50 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 with DFDBA<br>In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures. | Procedure: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)<br>* In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier.The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.<br>|
| Active Comparator: Collagen membrane and DFDBA<br>After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps. | Procedure: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)<br>* After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then 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 |
| --- | --- | --- |
| Change in clinical attachment level (CAL) | CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth. | CAL will be measured at base line, 3, 6, 9, 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pobing Depth (PD) | PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth. | PD will be measured at base line, 3, 6, 9, 12 months postoperative | 
| Gingival Recession Depth (RD) | RD will be measured from the CEJ to the most apical extension of the gingival margin using UNC periodontal probe at six sites per tooth | RD will be measured at base line, 3, 6, 9, 12 months postoperative | 
| Radiographic defect fill (IBD) | IBD will be measured from the alveolar bone crest to the base of the defect at baseline and after 6 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 IBD depth was measured by a computer-aided software program | IBD will be measured at base line, 3, 6, 9, 12 months postoperative | 
| Post-surgical patient satisfaction | A 3-item questionnaire will be asked to the patients and shall use a 7-point answer scale These items will be: • Would you experience the same surgery another time? Would you advice others with the surgery? To what extent are you satisfied with the results? | After 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage III periodontitis, APRF, Advanced Platelet Rich Fibrin, Demineralized freeze-dried bone allograft, DFDBA, Collagen Membrane, non-contained intraosseous defects, one wall intraosseous defects, combined 1- to 2-wall intraosseous defect