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Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.
The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:
will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin Platelet Rich Fibrin (Alb-PRF) | Experimental | For the production of Alb-PRF membrane, two 10 ml vacuum plastic tubes will be centrifuged at 700 g for 8 minutes. After centrifugation, the upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet-poor plasma (PPP) will be collected in a syringe and then will be heated in a heat block device at 75°C for 10 minutes to create denatured albumin (albumin gel). After heating, the albumin gel will be cooled to room temperature for approximately 10 minutes. An injectable albumin gel was then prepared. The liquid platelet-rich layer (liquid-PRF), including the buffy coat layer with accumulated platelets, leukocytes and growth factors, will be collected in a separate syringe and will be reserved at room temperature (20°C). The albumin gel and liquid PRF will be then thoroughly mixed by utilizing a female-female luer lock connector |
|
| Minimally Invasive Surgical Technique (MIST) | Active Comparator | Surgical approach will be the Minimally Invasive Surgical Technique (MIST) approach according to; simplified or modified papilla-preservation flap design upon the papilla width. Defects will be thoroughly debrided using Gracey curettes and ultrasonic scalers. Then, a single internal mattress suture using 5-0 polypropylene sutures will be placed at the defect-associated inter-dental area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) | Procedure | Albumin-PRF will be placed into intrabony defect |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (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, 6, and 9 months postoperative |
| 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. | CAL will be measured at base line, 6, and 9 months postoperative |
| Radiographic Linear Defect Depth (RLDD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mashaal Mohammed, Master | Contact | 00201094483995 | mashaal.abdullah@dentistry.cu.edu.eg | |
| Manal Hosny, Professor | Contact | manhosny@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Manal Hosny, Professor | Cairo University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31959025 | Result | Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20. | |
| 33160335 | Result |
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starting 6 months after publication
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Due to the type of intervention, only the outcome assessor and the statistician will be blinded
| Minimally invasive surgical technique (MIST) | Procedure | MIST will be the surgical access for treatment of Intrabony defect |
|
Individually customized bite blocks will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. Periapical radiograph PSP sensor size two and standardized exposure setting of 60 kVp, 8 mA, 0.7 mm, and 0.10 s will be used. RLDD will be measured as the depth of the intrabony defect from the alveolar crest (AC) to the defect base (DB) |
| Radiographic defect fill will be measured at base line, 6, and 9 months postoperative |
| 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, 6, and 9 months postoperative |
| Post-operative Pain | The visual analogue scale (VAS) score (0-10) | During first week postoperative |
| Radiographic defect fill (RDF) | Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values | Radiographic defect fill will be measured at base line, 6, and 9 months postoperative |
| Miron RJ, Chai J, Fujioka-Kobayashi M, Sculean A, Zhang Y. Evaluation of 24 protocols for the production of platelet-rich fibrin. BMC Oral Health. 2020 Nov 7;20(1):310. doi: 10.1186/s12903-020-01299-w. |
| 29926951 | Result | Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721. |
| 33778163 | Result | Pavlovic V, Ciric M, Jovanovic V, Trandafilovic M, Stojanovic P. Platelet-rich fibrin: Basics of biological actions and protocol modifications. Open Med (Wars). 2021 Mar 22;16(1):446-454. doi: 10.1515/med-2021-0259. eCollection 2021. |
| 37002441 | Result | Alshoiby MM, Fawzy El-Sayed KM, Elbattawy W, Hosny MM. Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jul;27(7):3457-3467. doi: 10.1007/s00784-023-04954-y. Epub 2023 Mar 31. |
| 32531175 | Result | Gheno E, Mourao CFAB, Mello-Machado RC, Stellet Lourenco E, Miron RJ, Catarino KFF, Alves AT, Alves GG, Calasans-Maia MD. In vivo evaluation of the biocompatibility and biodegradation of a new denatured plasma membrane combined with liquid PRF (Alb-PRF). Platelets. 2021 May 19;32(4):542-554. doi: 10.1080/09537104.2020.1775188. Epub 2020 Jun 12. |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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