TY - JOUR
T1 - Polyphosphate (PolyP) for alveolar cleft repair
T2 - study protocol for a pilot randomized controlled trial
AU - Alkaabi, S. A.
AU - Natsir Kalla, D. S.
AU - Alsabri, G. A.
AU - Fauzi, A.
AU - Tajrin, A.
AU - Müller, W. E.G.
AU - Schröder, H. C.
AU - Wang, X. G.
AU - Forouzanfar, T.
AU - Helder, M. N.
AU - Ruslin, M.
AU - Mueller, W. E. G.
N1 - Publisher Copyright: © 2021, The Author(s).
PY - 2021/6/14
Y1 - 2021/6/14
N2 - 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
AB - 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
KW - Alveolar bone grafting
KW - Bone regeneration
KW - Polyphosphate
KW - Regenerative medicine
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U2 - https://doi.org/10.1186/s13063-021-05325-2
DO - https://doi.org/10.1186/s13063-021-05325-2
M3 - Article
C2 - 34127045
SN - 1745-6215
VL - 22
SP - 1
EP - 8
JO - Trials
JF - Trials
IS - 1
M1 - 393
ER -