Advanced Platelet Rich Fibrin in Periodontal Angular Defects

Study Overview
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Brief Summary
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The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis.

Detailed Description
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Biphasic alloplasts have been successfully used in management of intrabony defects. Advanced platelet-rich fibrin is believed to contain higher amount of growth factors and white blood cells than the well known PRF. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate the effect of the A-PRF. Therefore, a randomized controlled clinical trial was conducted to compare the healing of intrabony defects treated with A-PRF/biphasic alloplast combination and to those obtained with biphasic alloplast mixed with saline. Using a parallel arm design, 22 intrabony defects were randomly treated with either biphasic alloplast mixed with saline (control group) or with A-PRF/ biphasic alloplast combination (test group). The following clinical parameters were recorded at baseline, three and six months postoperatively : plaque index (PI), modified gingival index (MGI), probing depth (PD), clinical attachment level (CAL), while these radiographic measurements were recorded at baseline and six months postoperatively: bone fill and bone density.

Official Title
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Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects

Conditions
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Intrabony Periodontal Defect

Intervention / Treatment
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* Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplast
* Procedure: Biphasic alloplast mixed with saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999) Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect. Patient's age between 25 to 55 years. Both sexes. No periodontal surgeries in the area of interest during the previous 6 months. The presence of intrabony defects (IBD) ≥3 mm deep (distance between alveolar crest and deepest point in the defect estimated from radiographs and confirmed upon surgical exposure). An interproximal probing depth (PD) ≥5 mm and clinical attachment loss (CAL) ≥3mm after phase I therapy in maxillary/ mandibular teeth. The presence of an adequate zone of keratinized gingiva at the facial aspect of the selected tooth. Exclusion Criteria: Patients who could not maintain O'leary plaque index (54) ≤10% after phase I therapy. Aggressive periodontitis patients. Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy. Pregnancy/lactation. Smoking and tobacco use in any form. Non vital teeth and teeth with grade III mobility.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 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
Interventional Model Description: This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups: Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin & biphasic alloplast) Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group I (Test)<br>Advanced platelet-rich fibrin mixed with biphasic alloplast | Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplast<br>* mucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.<br>|
| Active Comparator: Group II (control)<br>Biphasic alloplast mixed with saline | Procedure: Biphasic alloplast mixed with saline<br>* mucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level change | The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline , 3 and 6 months postoperatively | Baseline , 3 and 6 months posoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth change: | The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively | Baseline , 3 and 6 months postoperatively | 
| Radiographic bone density | Measuring the bone density before and after the procedure using CBCT | Baseline and 6 months postoperatively | 
| Radiographic bone fill | The actual bone formation in the intrabony defect measured on a CBCT in comparison to the baseline CBCT | Baseline and 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced platelet-rich fibrin