Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes

Study Overview
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Brief Summary
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For patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied in the bony defects) with resorbable collagen membranes. Clinical Outcomes recorded were the Plaque index (PI), Gingival index (GI), probing depth reduction (PD), Clinical attachment level (CAL), and radiographic defect depth changes. For the biochemical evaluation: levels of PDGF-BB and VEGF obtained from crevicular fluid by Perio-Paper strips were assessed using ELIZA.

Detailed Description
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Patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the present study. They have to be free from any systemic disease that contraindicates periodontal surgeries. Baseline data are obtained including the GI, PI, PD, CAL and preoperative paralleling periapical radiographs. Full thickness mucoperiosteal flaps are elevated and thorough debridement of the periodontal bony defect is performed. for OFD group; following debridement and saline irrigation, wound closure proceeds. for the L-PRF group; L-PRF is prepared and applied within the defect before primary closure. for the L-PRF + CM: similar procedure like the second group is performed but with an additional protective layer of collagen membrane on top of the defect before wound closure. from the second day postoperative; Periopaper strips are used to obtain a crevicular fluid sample from the sulcus At 6 months postoperative: the same baseline clinical measurements are obtained.

Official Title
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Treatment of Periodontal Intrabony Defects With Dense Leukocyte and Platelet-Rich Fibrin (L-PRF) Membrane Alone or in Combination With Collagen Membranes (Randomized Clinical and Biochemical Trial)

Conditions
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Periodontal Bone Loss, Periodontal Diseases

Intervention / Treatment
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* Procedure: L-PRF
* Procedure: OFD
* Procedure: CM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution 2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth Exclusion Criteria: Systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood Patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months Vulnerable groups Interdental craters and 1 wall osseous defects Active periapical pathosis

Ages Eligible for Study
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Minimum Age: 30 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 |
| --- | --- |
| Placebo Comparator: Open Flap Debridement<br>Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion | Procedure: OFD<br>* Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.<br>* Other names: Open flap Debridement;|
| Active Comparator: L-PRF<br>Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect | Procedure: L-PRF<br>* a blood sample is obtained from the patient, and centrifuged to prepare a leukocyte platelet rich fibrin harvest that is applied within the derided lesion.<br>* Other names: Leukocyte platelet rich fibrin;Procedure: OFD<br>* Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.<br>* Other names: Open flap Debridement;|
| Active Comparator: L-PRF + CM<br>Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect and coverage with collagen xenogeneic membrane | Procedure: L-PRF<br>* a blood sample is obtained from the patient, and centrifuged to prepare a leukocyte platelet rich fibrin harvest that is applied within the derided lesion.<br>* Other names: Leukocyte platelet rich fibrin;Procedure: OFD<br>* Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.<br>* Other names: Open flap Debridement;Procedure: CM<br>* Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects<br>* Other names: Collagen membrane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival index | measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation | 6 months | 
| Plaque index | measures the score of plaque accumulation. Minimum value of 0: denotes absence of plaque on teeth surfaces. Maximum value = 3 and denotes diffuse and abundant plaque accumulation on teeth surfaces | 6 months | 
| Probing depth | measures the reduction in pocket depth | 6 months | 
| Clinical attachment level | measures the changes in amount of periodontal attachment | 6 months | 
| CEJ to base of defect | measures the changes in bone defect depth | 6 months | 
| CEJ to alveolar crest | measures the amount of crystal bone changes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDGF | Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB | 31 days | 
| VEGF | Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor | 31 days |