Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study

Abstract Background Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium pho...

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Autores principales:	Salem A. Alkaabi, Diandra Sabrina Natsir Kalla, Ghamdan A. Alsabri, Abul Fauzi, Nova Jansen, Andi Tajrin, Rifaat Nurrahma, Werner Müller, Heinz C. Schröder, Wang Xiaohong, Tymour Forouzanfar, Marco N. Helder, Muhammad Ruslin
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Polyphosphate Alveolar bone grafting Bone regeneration Regenerative medicine Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/ba58acd7b3f14ca689a85b113bd40cc2
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spelling	oai:doaj.org-article:ba58acd7b3f14ca689a85b113bd40cc22021-11-14T12:12:40ZSafety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study10.1186/s40814-021-00939-42055-5784https://doaj.org/article/ba58acd7b3f14ca689a85b113bd40cc22021-11-01T00:00:00Zhttps://doi.org/10.1186/s40814-021-00939-4https://doaj.org/toc/2055-5784Abstract Background Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or in combination with BCP, in a first-in-human clinical trial. Methods This single-blinded, parallel, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13–34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was 6 months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations. Osteoinductivity evaluation using histomorphometric analysis of biopsies was not possible due to COVID restrictions. Results Due to surgical and feasibility reasons, eventually, only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day 180). Three out of eight were unable to reach the hospital due to COVID-19 restrictions. One patient decided not to continue with the study. None of the patients showed any allergic reactions or any remarkable local or systematic side effects. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients who got the BCP/Ca-polyP MPs combination had scores ranging from I to III. Conclusions Our results indicate that Ca-polyP MPs and the BCP/Ca-polyP MPs combination appear to be safe graft materials; however, in the current setting, Ca-polyP MPs alone may not be a sufficiently stable defect-filling scaffold to be used in alveolar cleft repair. Trial registration Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019 .Salem A. AlkaabiDiandra Sabrina Natsir KallaGhamdan A. AlsabriAbul FauziNova JansenAndi TajrinRifaat NurrahmaWerner MüllerHeinz C. SchröderWang XiaohongTymour ForouzanfarMarco N. HelderMuhammad RuslinBMCarticlePolyphosphateAlveolar bone graftingBone regenerationRegenerative medicineMedicine (General)R5-920ENPilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Polyphosphate Alveolar bone grafting Bone regeneration Regenerative medicine Medicine (General) R5-920
spellingShingle	Polyphosphate Alveolar bone grafting Bone regeneration Regenerative medicine Medicine (General) R5-920 Salem A. Alkaabi Diandra Sabrina Natsir Kalla Ghamdan A. Alsabri Abul Fauzi Nova Jansen Andi Tajrin Rifaat Nurrahma Werner Müller Heinz C. Schröder Wang Xiaohong Tymour Forouzanfar Marco N. Helder Muhammad Ruslin Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
description	Abstract Background Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or in combination with BCP, in a first-in-human clinical trial. Methods This single-blinded, parallel, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13–34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was 6 months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations. Osteoinductivity evaluation using histomorphometric analysis of biopsies was not possible due to COVID restrictions. Results Due to surgical and feasibility reasons, eventually, only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day 180). Three out of eight were unable to reach the hospital due to COVID-19 restrictions. One patient decided not to continue with the study. None of the patients showed any allergic reactions or any remarkable local or systematic side effects. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients who got the BCP/Ca-polyP MPs combination had scores ranging from I to III. Conclusions Our results indicate that Ca-polyP MPs and the BCP/Ca-polyP MPs combination appear to be safe graft materials; however, in the current setting, Ca-polyP MPs alone may not be a sufficiently stable defect-filling scaffold to be used in alveolar cleft repair. Trial registration Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019 .
format	article
author	Salem A. Alkaabi Diandra Sabrina Natsir Kalla Ghamdan A. Alsabri Abul Fauzi Nova Jansen Andi Tajrin Rifaat Nurrahma Werner Müller Heinz C. Schröder Wang Xiaohong Tymour Forouzanfar Marco N. Helder Muhammad Ruslin
author_facet	Salem A. Alkaabi Diandra Sabrina Natsir Kalla Ghamdan A. Alsabri Abul Fauzi Nova Jansen Andi Tajrin Rifaat Nurrahma Werner Müller Heinz C. Schröder Wang Xiaohong Tymour Forouzanfar Marco N. Helder Muhammad Ruslin
author_sort	Salem A. Alkaabi
title	Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
title_short	Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
title_full	Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
title_fullStr	Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
title_full_unstemmed	Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
title_sort	safety and feasibility study of using polyphosphate (polyp) in alveolar cleft repair: a pilot study
publisher	BMC
publishDate	2021
url	https://doaj.org/article/ba58acd7b3f14ca689a85b113bd40cc2
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Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study

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