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

Purpose: Carbonate apatite (CO(3)Ap), an inorganic component of human bone, can be fabricated in chemically pure form from calcium carbonate block via a dissolution-precipitation reaction. A first-in-human clinical trial was conducted in which low-crystalline CO(3)Ap granules were evaluated for safety and efficacy in sinus floor augmentation and simultaneous implant installation. Materials and Methods: Procedures were performed in 8 patients (9 implants) with 2 granule sizes: small (300 to 600 mu m) and medium (600 to 1,000 mu m). Panoramic radiographic assessment was performed immediately after augmentation, 7 +/- 2 months after augmentation, 6 +/- 2 months after prosthetic loading, and 12 +/- 2 months after prosthetic loading. Results: 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 +/- 0.8 mm preoperatively and increased to 14.0 +/- 1.9 mm after augmentation. Implants 9.0 to 11.5 mm in length were placed. The post-augmentation height decreased to 12.4 +/- 1.3 mm at 7 +/- 2 months; after prosthetic loading, it decreased to 11.9 +/- 0.8 mm at 6 +/- 2 months and 11.7 +/- 0.6 mm at 12 +/- 2 months. 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. Conclusions: Low-crystalline CO(3)Ap granules were useful and safe for sinus floor augmentation and simultaneous implant installation, providing a promising bone substitute for dental implant surgery. (C) 2019 Published by Elsevier Inc. on behalf of the American Association of Oral and Maxillofacial Surgeons