Related Experiment Video
Updated: Oct 14, 2025
Biological Compatibility Profile on Biomaterials for Bone Regeneration
Published on: November 16, 2018
Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study
Salem A Alkaabi1,2, Diandra Sabrina Natsir Kalla3,4, Ghamdan A Alsabri3
1Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands. al_kaabi33@hotmail.com.
Insights
Calcium polyP microparticles (Ca-polyP MPs) show safety in alveolar cleft repair. While the combination with biphasic calcium phosphate (BCP) demonstrated promising radiographic results, Ca-polyP MPs alone may not provide sufficient scaffold stability.
Area of Science:
- Biomaterials Science
- Regenerative Medicine
- Orthopedic Surgery
Background:
- Alveolar bone defects in cleft palate patients require bone grafting.
- Polyphosphate (PolyP) acts as a phosphate source for bone mineralization and provides energy for regeneration.
- Calcium polyP microparticles (Ca-polyP MPs) exhibit osteoinductive properties.
Purpose of the Study:
- To assess the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or with BCP, in a human clinical trial.
- To evaluate Ca-polyP MPs as a potential bone graft material for alveolar cleft reconstruction.
Main Methods:
- A single-blinded, prospective pilot study involving eight adolescent patients with alveolar bone cleft.
- Patients were randomized into two groups: Ca-polyP MPs alone or a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP).
- Follow-up included safety monitoring via radiography, blood tests, and physical examinations for 6 months.
Main Results:
- Only two patients received Ca-polyP MPs alone; the rest received the combination graft.
- No allergic or significant local/systemic side effects were observed.
- Radiographic assessment showed grade IV Bergland scale for Ca-polyP MPs alone, versus grades I-III for the BCP/Ca-polyP MPs combination.
Conclusions:
- Ca-polyP MPs and the BCP/Ca-polyP MPs combination are safe for alveolar cleft repair.
- Ca-polyP MPs alone may lack sufficient stability as a defect-filling scaffold.
- The combination graft shows potential for improved radiographic outcomes in alveolar cleft reconstruction.
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 .
More Related Videos
12:22Synthesis of Thermogelling PolyN-isopropylacrylamide-graft-chondroitin Sulfate Composites with Alginate Microparticles for Tissue Engineering
Published on: October 26, 2016
14:49Direct and Indirect Culture Methods for Studying Biodegradable Implant Materials In Vitro
Published on: April 15, 2022