Injectable Platelet Rich Fibrin With Demineralized Freeze-dried Bone Allograft in Treatment of Intraosseous Defects

Study Overview
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Brief Summary
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Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients.

Detailed Description
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Intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest. In a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported. Treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy. Current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.

Official Title
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Clinical and Radiographic Evaluation of Injectable PRF With Demineralized Freeze-Dried Bone Allograft (DFDBA) Compared to (DFDBA) in Treatment of Intraosseous Defects 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: Injectable platelet rich fibrin combined with DFDBA
* Procedure: Demineralized Freeze Dried Bone Allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 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 ≥ 5 mm and pocket depth ≥ 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: Injectable Platelet Rich Fibrin (i-PRF) with DFDBA<br>In i-PRF assigned group, 10 cc of blood per intraosseous defect will be collected right after administering the anaesthesia and will be processed according to the technique proposed by Choukroun et al., 2017 (centrifuged at 700 rpm, for 2-3 minutes). The yellow part will be collected using a syringe and added to a cup that contains the bone grafting material. The i-PRF consolidated bone graft will placed into the intraosseous defect. | Procedure: Injectable platelet rich fibrin combined with DFDBA<br>* The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect<br>|
| Active Comparator: Demineralized Freeze-Dried Bone Allograft (DFDBA) alone<br>After debridement and intraoperative recordings, in the control group, the bone graft material will be placed in the intraosseous defect without overfilling. | Procedure: Demineralized Freeze Dried Bone Allograft<br>* Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level gain (CAL) | CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth. | CAL will be measured at base line, 3, 6, and 9 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth (PD) | PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth. | PD will be measured at base line, 3, 6, and 9 months postoperative | 
| Radiographic defect fill (IBD) | The depth of intrabony defect will be measured from the alveolar bone crest to the base of the defect at baseline, six months and after nine months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiograph. Radiographs will be scanned and the radiographic defect fill depth will be measured by a computer-aided software program | Radiographic defect fill will be measured at base line, 6, and 9 months postoperative | 
| Gingival Recession Depth (RD) | RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth. | RD will be measured at base line, 3, 6, and 9 months postoperative | 
| Post-surgical patient satisfaction | A 3-item questionnaire will be asked to the patients and shall use a 7-points 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? 7 points mean the best 1 means the worst | After 9 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injectable platelet rich fibrin, I-PRF, Demineralized Freeze-Dried Bone Allograft, DFDBA, Stage 3 periodontitis, 3 wall intraosseous defect, 2 wall intraosseous defect