Maxillary sinus floor augmentation using low-crystalline carbonate apatite granules with simultaneous implant installation: First-in-human clinical trial

Publication date: Available online 6 December 2018

Source: Journal of Oral and Maxillofacial Surgery

Author(s): Keiko Kudoh, Naoyuki Fukuda, Shohei Kasugai, Noriko Tachikawa, Kiyoshi Koyano, Yasuyuki Matsushita, Yoichiro Ogino, Kunio Ishikawa, Youji Miyamoto

Abstract

Purpose

Carbonate apatite (CO₃Ap), an inorganic component of human bone, can be fabricated in chemically pure form from calcium carbonate block via dissolution-precipitation. 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 on 8 patients (9 implants) with two granule sizes: S (300–600 μm) and M (600–1000 μm). Panoramic radiographic assessment was performed immediately after and 7 ± 2 months after augmentation, and 6 ± 2 months 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 preoperative residual maxillary molar bone height of 5.2 ± 0.8 mm increased to 14.0 ± 1.9 mm after augmentation. Implants 9.0 -11.5 mm in length were placed. Post-augmentation heights decreased to 12.4 ± 1.3 mm at 7 ± 2 months, and after prosthetic loading 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 failure 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.

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