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

PURPOSE: Carbonate apatite (CO3Ap), 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 CO3Ap 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 μm) and medium (600 to 1,000 μm). 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 CO3Ap granules were useful and safe for sinus floor augmentation and simultaneous implant installation, providing a promising bone substitute for dental implant surgery.