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

Trials

A. Fauzi¹  A. Tajrin¹  M. Ruslin¹  G. A. Alsabri²  D. S. Natsir Kalla³  S. A. Alkaabi⁴  M. N. Helder⁵  T. Forouzanfar⁵  X. G. Wang⁶  W. E. G. Müller⁷  H. C. Schröder⁷ 

[1] Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, 90425, Makassar, Indonesia;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, The Netherlands;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, The Netherlands;Department of Biochemistry, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia;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, The Netherlands;Department of Oral and Maxillofacial Surgery, Al Kuwait Hospital, Ministry of Health, Dubai, United Arab Emirates;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, The Netherlands;Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, 90425, Makassar, Indonesia;Institut für Physiologische Chemie, Angewandte Molekularbiologie, Universitätsmedizin, Johannes Gutenberg-Universität Mainz, Mainz, Germany;Institut für Physiologische Chemie, Angewandte Molekularbiologie, Universitätsmedizin, Johannes Gutenberg-Universität Mainz, Mainz, Germany;NanotecMARIN GmbH, Mainz, Germany;

关键词: Polyphosphate;    Alveolar bone grafting;    Bone regeneration;    Regenerative medicine;   

DOI  :  10.1186/s13063-021-05325-2

来源: Springer

【 摘 要 】

ObjectiveBone 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.AimTo evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs as a bone-inducing graft material in humans.MethodsThis 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.DiscussionThis 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 registrationIndonesian Trial Registry INA-EW74C1N. Registered on 12 June 2020

【 授权许可】

CC BY