1 research outputs found
Synthetic biomaterials based on hydroxyapatite and tricalcium phosphate: analysis of current clinical trials
Introduction To date, a wide variety of synthetic materials, including metals, polymers and ceramics, have
been proposed and used as a substitute for bone grafts in the field of traumatology/orthopedics, neurosurgery
and oral and maxillofacial surgery (OMFS). However, the most studied materials are calcium phosphate
ceramics (CPC), in particular hydroxyapatite and tricalcium phosphate, as well as their mixtures, called
byphasic calcium phosphates. This interest stems from the fact that the main component of bone is the apatite
mineral calcium phosphate. Hydroxyapatite and tricalcium phosphate are among the most commonly used
and effective synthetic substitutes for bone grafts. They have not only osteoconductive properties, but also
osteoinductive. These properties, combined with cell-mediated resorption, ensure complete regeneration
of bone defects. This study will analyze existing clinical trials, registered on the clinicaltirals.gov website,
on the use of hydroxyapatite and tricalcium phosphate in the field of traumatology and orthopedics,
neurosurgery and OMFS.
Aim To identify the potential for clinical use, as well as possible side effects, of CPC as a replacement for bone
grafts.
Materials and methods The search strategy was to use material from the clinicaltrials.gov website,
which focused on key terms such as hydroxyapatite, tricalcium phosphate, hydroxyapatite and tricalcium
phosphate, traumatology and orthopedics, maxillofacial surgery, dentistry, neurosurgery, bone, и diseases
of the musculoskeletal system.
Results and discussion As of November 2022, there were approximately 85 clinical trials with hydroxyapatite
application, approximately 49 clinical trials with tricalcium phosphate, and approximately 16 clinical trials
with the hydroxyapatite/tricalcium phosphate combination. Most of the studies were Phase 1-2, Phase 2,
or Phase 4. Most focused on tibial trauma therapy, osteoporosis/osteopenia, alveolar bone resorption, and
spinal surgery. It was found that full results were published only in 3, 7 and 2 clinical trials on the use
of hydroxyapatite, tricalcium phosphate and their combination, respectfully. All clinical trials had similar
preparation methods and all of those clinical trials produced positive results without serious side effects.
Conclusion There is a wide potential for clinical use of CPC as synthetic bone graft substitutes without reports
of serious side effects. Many preclinical and clinical studies are currently underway on the use of hydroxyapatite
and tricalcium phosphate, and their future results will further explore their clinical potential