Polyphosphate (PolyP) for alveolar cleft repair: study protocol for a pilot randomized controlled trial

Alkaabi S.A., Natsir Kalla D.S., Alsabri G.A., Fauzi A., Tajrin A., Müller W.E.G., Schröder H.C., Wang X.G., Forouzanfar T., Helder M.N., Ruslin M.

Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Department of Oral and Maxillofacial Surgery, Al Kuwait Hospital, Ministry of Health, Dubai, United Arab Emirates; Department of Biochemistry, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia; Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, 90425, Indonesia; Institut für Physiologische Chemie, Angewandte Molekularbiologie, Universitätsmedizin, Johannes Gutenberg-Universität Mainz, Mainz, Germany; NanotecMARIN GmbH, Mainz, Germany


Abstract

Objective: Bone grafting is an important surgical procedure to restore missing bone in patients with alveolar cleft lip/palate, aiming to stabilize either sides of the maxillary segments by inducing new bone formation, and in bilateral cleft cases also to stabilize the pre-maxilla. Polyphosphate (PolyP), a physiological polymer composed of orthophosphate units linked together with high-energy phosphate bonds, is a naturally existing compound in platelets which, when complexed with calcium as Ca-polyP microparticles (Ca-polyP MPs), was proven to have osteoinductive properties in preclinical studies. Aim: To evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs as a bone-inducing graft material in humans. Methods: This prospective non-blinded first-in-man clinical pilot study shall consist of 8 alveolar cleft patients of 13 years or older to evaluate the feasibility and safety of Ca-PolyP MPs as a bone-inducing graft material. Patients will receive Ca-polyP graft material only or Ca-polyP in combination with biphasic calcium phosphate (BCP) as a bone substitute carrier. During the trial, the participants will be investigated closely for safety parameters using radiographic imaging, regular blood tests, and physical examinations. After 6 months, a hollow drill will be used to prepare the implantation site to obtain a biopsy. The radiographic imaging will be used for clinical evaluation; the biopsy will be processed for histological/histomorphometric evaluation of bone formation. Discussion: This is the first-in-man study evaluating the safety and feasibility of the polyP as well as the potential regenerative capacity of polyP using an alveolar cleft model. Trial registration: Indonesian Trial Registry INA-EW74C1N. Registered on 12 June 2020 © 2021, The Author(s).

Alveolar bone grafting; Bone regeneration; Polyphosphate; Regenerative medicine


Journal

Trials

Publisher: BioMed Central Ltd

Volume 22, Issue 1, Art No 393, Page – , Page Count


Journal Link: https://www.scopus.com/inward/record.uri?eid=2-s2.0-85107848904&doi=10.1186%2fs13063-021-05325-2&partnerID=40&md5=7519f24f4ac45c113b9f826601a75f2e

doi: 10.1186/s13063-021-05325-2

Issn: 17456215

Type: All Open Access, Gold, Green


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