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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)985.e1-985.e11
JournalJournal of Oral and Maxillofacial Surgery
Volume77
Issue number5
DOIs
Publication statusPublished - May 1 2019

Fingerprint

Sinus Floor Augmentation
Carbon Monoxide
Clinical Trials
Bone Substitutes
Osseointegration
Bone and Bones
Dental Implants
Calcium Carbonate
Maxilla
Bone Resorption
Survival Rate
Hemorrhage
Safety
Pain
carboapatite

All Science Journal Classification (ASJC) codes

  • Surgery
  • Oral Surgery
  • Otorhinolaryngology

Cite this

Maxillary Sinus Floor Augmentation Using Low-Crystalline Carbonate Apatite Granules With Simultaneous Implant Installation : First-in-Human Clinical Trial. / Kudoh, Keiko; Fukuda, Naoyuki; Kasugai, Shohei; Tachikawa, Noriko; Koyano, Kiyoshi; Matsushita, Yasuyuki; Ogino, Yoichiro; Ishikawa, Kunio; Miyamoto, Youji.

In: Journal of Oral and Maxillofacial Surgery, Vol. 77, No. 5, 01.05.2019, p. 985.e1-985.e11.

Research output: Contribution to journalArticle

@article{ac1f1ab5746241b8951ca3ce6fa53ef0,
title = "Maxillary Sinus Floor Augmentation Using Low-Crystalline Carbonate Apatite Granules With Simultaneous Implant Installation: First-in-Human Clinical Trial",
abstract = "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.",
author = "Keiko Kudoh and Naoyuki Fukuda and Shohei Kasugai and Noriko Tachikawa and Kiyoshi Koyano and Yasuyuki Matsushita and Yoichiro Ogino and Kunio Ishikawa and Youji Miyamoto",
year = "2019",
month = "5",
day = "1",
doi = "10.1016/j.joms.2018.11.026",
language = "English",
volume = "77",
pages = "985.e1--985.e11",
journal = "Journal of Oral and Maxillofacial Surgery",
issn = "0278-2391",
publisher = "W.B. Saunders Ltd",
number = "5",

}

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

PY - 2019/5/1

Y1 - 2019/5/1

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.

UR - http://www.scopus.com/inward/record.url?scp=85061215753&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85061215753&partnerID=8YFLogxK

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 -