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

Keiko Kudoh, Naoyuki Fukuda, Shohei Kasugai, Noriko Tachikawa, Kiyoshi Koyano, Yasuyuki Matsushita, Yoichiro Ogino, Kunio Ishikawa, Youji Miyamoto

Journal: Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons 2020;77(5):985.e1-985.e11

PMID: 30597134

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Abstract

PURPOSE

Carbonate apatite (COAp), 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 COAp 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 COAp granules were useful and safe for sinus floor augmentation and simultaneous implant installation, providing a promising bone substitute for dental implant surgery.

Address: Assistant Professor, Department of Oral Surgery, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan. Electronic address: [email protected].; Assistant Professor, Department of Oral Surgery, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.; Professor, Dental Implant Clinic, Dental Hospital, Tokyo Medical and Dental University, Tokyo, Japan.; Associate Professor, Dental Implant Clinic, Dental Hospital, Tokyo Medical and Dental University, Tokyo, Japan.; Professor, Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.; Associate Professor, Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.; Professor, Department of Biomaterials, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.; Professor, Department of Oral Surgery, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.

DOI: 10.1016/j.joms.2018.11.026

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MeSH Terms: Apatites, Dental Implantation, Endosseous, Dental Implants, Dental Restoration Failure, Follow-Up Studies, Humans, Maxillary Sinus, Sinus Floor Augmentation, Treatment Outcome