Maxillary Sinus Floor Augmentation Using Low-Crystalline Carbonate Apatite Granules With Simultaneous Implant Installation: First-in-Human Clinical Trial

Abstract

Carbonate apatite (CO3Ap), an inorganic component of human bone, can be fabricated inchemically pure form from calcium carbonate block via a dissolution-precipitation reaction. A first-in-human clinical trial was conducted in which low-crystalline CO3Ap granules were evaluated for safety and efficacy in sinus floor augmentation and simultaneous implant installation. Procedures were performed in 8 patients (9 implants) with 2 granule sizes: small (300 to 600μm) and medium (600 to 1,000μm).Panoramic radiographic assessment was performed immediately after augmentation, 7±2months after augmentation, 6±2months after prosthetic loading, and 12±2months after prosthetic loading. Postoperative healing was uniformly uneventful, with no abnormal bleeding, pain, or swelling, and all implants achieved successful osseointegration. The mean residual maxillary molar bone height was 5.2±0.8mm preoperatively and increased to 14.0±1.9mm after augmentation. Implants 9.0 to 11.5mm in length were placed. The post-augmentation height decreased to 12.4±1.3mm at 7±2months; after prosthetic loading, it decreased to 11.9±0.8mm at 6±2months and 11.7±0.6mm at 12±2months. No abnormal bone resorption of the augmented areas was observed, and bone height supporting the implants was maintained. The overall implant survival rate was 100%, with no implant failures or complications during the first year. Low-crystalline CO3Ap granules were useful and safe for sinus floor augmentation and simultaneous implant installation, providing a promising bone substitute for dental implant surgery.