TY - JOUR
T1 - Maxillary Sinus Floor Augmentation Using Low-Crystalline Carbonate Apatite Granules With Simultaneous Implant Installation
T2 - First-in-Human Clinical Trial
AU - Kudoh, Keiko
AU - Fukuda, Naoyuki
AU - Kasugai, Shohei
AU - Tachikawa, Noriko
AU - Koyano, Kiyoshi
AU - Matsushita, Yasuyuki
AU - Ogino, Yoichiro
AU - Ishikawa, Kunio
AU - Miyamoto, Youji
N1 - Funding Information:
This clinical trial was funded by GC (Tokyo, Japan). However, GC had no further participation in conducting the study and exerted no control over the interpretation, authoring, or publication of the results of this work. This study was partially funded by the Japan Agency for Medical Research and Development under the Strategic Promotion of Innovative Research and Development Program (17im0502004h). We thank all the investigators who participated and, most of all, the patients for their important contributions to the study. We also thank Akira Tsuchiya (Kyushu University), as well as Kenji Fujisawa, Susumu Abe, Go Ohe, Takamitsu Mano, Yoshiko Yamamura, Kumiko Kamada, and Takayuki Nakagawa (Tokushima University Graduate School), for their critical support of this study.
PY - 2019/5
Y1 - 2019/5
N2 - 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 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 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.
AB - 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 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 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.
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U2 - 10.1016/j.joms.2018.11.026
DO - 10.1016/j.joms.2018.11.026
M3 - Article
C2 - 30597134
AN - SCOPUS:85061215753
VL - 77
SP - 985.e1-985.e11
JO - Journal of Oral and Maxillofacial Surgery
JF - Journal of Oral and Maxillofacial Surgery
SN - 0278-2391
IS - 5
ER -