Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients

Официальное название

Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin (Alb-PRF) Versus Minimally Invasive Surgical Technique (MIST) in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. A Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

• Процедура Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)
  Albumin-PRF will be placed into intrabony defect
• Процедура Minimally invasive surgical technique (MIST)
  MIST will be the surgical access for treatment of Intrabony defect

Первичные конечные точки

• Clinical attachment level (CAL) [Срок оценки: CAL will be measured at base line, 6, and 9 months postoperative]

Вторичные конечные точки (5)

• Probing Depth (PD) [Срок оценки: CAL will be measured at base line, 6, and 9 months postoperative]
• Radiographic Linear Defect Depth (RLDD) [Срок оценки: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative]
• Recession Depth (RD) [Срок оценки: RD will be measured at base line, 6, and 9 months postoperative]
• Post-operative Pain [Срок оценки: During first week postoperative]
• Radiographic defect fill (RDF) [Срок оценки: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative]

Критерии участия

Критерии включения

• Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area.
• Vital teeth.
• 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.
• Ability to sign an informed consent form.
• Patients age ≥18 years old.
• Patients who are cooperative, motivated, and hygiene conscious.
• Systemically free according to Cornell Medical Index.

Критерии исключения

• Patient undergoing orthodontic treatment.
• Pregnant females or breast feeding.
• Smokers.
• Teeth mobility greater than grade I.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 31959025
• 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. PMID 33160335
• 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 Clas PMID 29926951
• 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. PMID 33778163
• 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. PMID 37002441
• 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. PMID 32531175

Идентификаторы

NCT: NCT06297577 · MASH2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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