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.
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Authors | S A Alkaabi, D S Natsir Kalla, G A Alsabri, A Fauzi, A Tajrin, W E G Müller, H C Schröder, X G Wang, T Forouzanfar, M N Helder, M Ruslin |
Journal | Trials
(Trials)
Vol. 22
Issue 1
Pg. 393
(Jun 14 2021)
ISSN: 1745-6215 [Electronic] England |
PMID | 34127045
(Publication Type: Clinical Trial Protocol, Journal Article)
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Chemical References |
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Topics |
- Cleft Lip
(diagnostic imaging, surgery)
- Cleft Palate
(diagnostic imaging, surgery)
- Humans
- Indonesia
- Pilot Projects
- Polyphosphates
(adverse effects)
- Prospective Studies
- Randomized Controlled Trials as Topic
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