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Related Experiment Video

Updated: Nov 2, 2025

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

S A Alkaabi1,2, D S Natsir Kalla1,3, G A Alsabri1

  • 1Department 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.

Trials
|June 15, 2021
PubMed
Summary

This pilot study assessed calcium polyphosphate microparticles (Ca-polyP MPs) for bone regeneration in alveolar cleft patients. Results indicate Ca-polyP MPs are a feasible and safe bone graft material, showing potential for new bone formation.

Keywords:
Alveolar bone graftingBone regenerationPolyphosphateRegenerative medicine

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Area of Science:

  • Biomaterials Science
  • Regenerative Medicine
  • Oral and Maxillofacial Surgery

Background:

  • Bone grafting is crucial for alveolar cleft repair, aiming to stabilize maxillary segments and induce new bone formation.
  • Calcium polyphosphate microparticles (Ca-polyP MPs), derived from platelets, have demonstrated osteoinductive properties in preclinical research.
  • Alveolar bone grafting is essential for patients with cleft lip/palate to achieve functional and aesthetic outcomes.

Purpose of the Study:

  • To evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs as a bone-inducing graft material in human subjects.
  • To assess the potential of Ca-polyP MPs in promoting new bone formation within alveolar cleft defects.
  • To establish the safety profile of Ca-polyP MPs in a clinical setting for alveolar bone reconstruction.

Main Methods:

  • A prospective, non-blinded, first-in-man clinical pilot study involving 8 patients (≥13 years) with alveolar clefts.
  • Patients received either Ca-polyP MPs alone or combined with biphasic calcium phosphate (BCP) as a bone substitute carrier.
  • Safety was monitored via radiographic imaging, blood tests, and physical examinations; bone formation was evaluated through histological analysis of biopsies taken after 6 months.

Main Results:

  • The study demonstrated the feasibility and safety of using Ca-polyP MPs in human alveolar cleft bone grafting.
  • Radiographic and histological analyses provided evidence of new bone formation at the graft sites.
  • No significant adverse events related to the Ca-polyP MPs were reported during the monitoring period.

Conclusions:

  • This first-in-man study confirms the safety and feasibility of polyphosphate (PolyP) as a bone graft material in an alveolar cleft model.
  • Ca-polyP MPs show potential as a regenerative capacity for bone induction in humans.
  • Further research is warranted to fully elucidate the regenerative potential of PolyP in bone reconstruction.