J Periodontal Implant Sci.  2019 Dec;49(6):382-396. 10.5051/jpis.2019.49.6.382.

Application of low-crystalline carbonate apatite granules in 2-stage sinus floor augmentation: a prospective clinical trial and histomorphometric evaluation

• Nakagawa T
• Kudoh K
• Fukuda N
• Kasugai S
• Tachikawa
• Koyano K
• Matsushita Y
• Sasaki M
• Ishikawa K
• Miyamoto Y

• KMID: 2465382
• DOI: http://doi.org/10.5051/jpis.2019.49.6.382

Abstract

PURPOSE
The purpose of this study was to elucidate the efficacy and safety of carbonate apatite (CO₃Ap) granules in 2-stage sinus floor augmentation through the radiographic and histomorphometric assessment of bone biopsy specimens.
METHODS
Two-stage sinus floor augmentation was performed on 13 patients with a total of 17 implants. Radiographic assessment using panoramic radiographs was performed immediately after augmentation and was also performed 2 additional times, at 7±2 months and 18±2 months post-augmentation, respectively. Bone biopsy specimens taken from planned implant placement sites underwent micro-computed tomography, after which histological sections were prepared.
RESULTS
Postoperative healing of the sinus floor augmentation was uneventful in all cases. The mean preoperative residual bone height was 3.5±1.3 mm, and this was increased to 13.3±1.7 mm by augmentation with the CO₃Ap granules. The mean height of the augmented site had decreased to 10.7±1.9 mm by 7±2 months after augmentation; however, implants with lengths in the range of 6.5 to 11.5 mm could still be placed. The mean height of the augmented site had decreased to 9.6±1.4 mm by 18±2 months post-augmentation. No implant failure or complications were observed. Few inflammatory cells or foreign body giant cells were observed in the bone biopsy specimens. Although there were individual differences in the amount of new bone detected, new bone was observed to be in direct contact with the CO₃Ap granules in all cases, without an intermediate layer of fibrous tissue. The amounts of bone and residual CO₃Ap were 33.8%±15.1% and 15.3%±11.9%, respectively.
CONCLUSIONS
In this first demonstration, low-crystalline CO₃Ap granules showed excellent biocompatibility, and bone biopsy showed them to be replaced with bone in humans. CO₃Ap granules are a useful and safe bone substitute for two-stage sinus floor augmentation.

Keyword

Apatites; Dental implant; Sinus floor augmentation

MeSH Terms

Apatites
Biopsy
Bone Substitutes
Carbon*
Dental Implants
Giant Cells, Foreign-Body
Humans
Individuality
Prospective Studies*
Sinus Floor Augmentation*
Apatites
Bone Substitutes
Carbon
Dental Implants

Figure

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  Figure 1 Treatment protocol (upper section) and time schedule of evaluations using panoramic radiographs (lower section). Panoramic radiographs were taken i) pre-sinus floor augmentation, ii) immediately after augmentation, iii) 7±2 months after augmentation, and iv) 18±2 months after augmentation. CO3Ap: carbonate apatite.

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  Figure 2 Diagram of the measurement of EBH at the planned implant placement site. CO3Ap: carbonate apatite, EBH: elevated bone height.

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  Figure 3 EBH at the implant placement site. Statistically significant differences were observed in comparison to the EBH measured immediately after the augmentation. EBH: elevated bone height. a)P<0.01.

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  Figure 4 Graft material and surgical views of maxillary sinus floor augmentation and implant placement (case 10). (A) The CO3Ap granules used in this clinical trial. (B) Preparation of the recipient site of the elevated space. (C) The elevated space filled with CO3Ap granules. (D) Implant placement observed 8 months after augmentation. CO3Ap: carbonate apatite.

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  Figure 5 Radiographic examinations (case 10). Panoramic radiographs taken (A) pre-augmentation, (B) immediately after augmentation, (C) 7 months after augmentation, and (D) 18 months after augmentation. Arrowheads indicate the boundary line between residual bone and CO3Ap granules (B, C). Black arrows indicate the grafted sinus floor line, which is elevated by augmentation with CO3Ap granules (B-D). CT images of preoperative residual bone height at site #16 (1.4 mm) (E) and the elevated bone height at 7 months after augmentation of the same site (17.0 mm) (F). The bone height was maintained until implant placement. A micro-CT image of the bone biopsy sample taken 8 months after augmentation (G). Newly formed bone (white arrows) in direct contact with CO3Ap granules (*). CO3Ap: carbonate apatite, CT: computed tomography.

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  Figure 6 A histological microphotograph of case 8 taken 7 months after augmentation. (A) A lower-magnification image of the relevant section of the biopsy specimen. The amounts of NB and residual CO3Ap (*) were 43.8% and 13.2%, respectively. (B) Few inflammatory cells or foreign body giant cells were observed around the CO3Ap granules (*). (C) New bone was observed to be in direct contact with the CO3Ap granules (*) with no intermediate fibrous tissue. (D) Black arrowheads indicate the area of replacement of CO3Ap granules (*) with new bone. (E) A higher-magnification image. Arrows indicate that osteoblasts were observed on the surface of new bone. Asterisk indicates residual CO3Ap. (F) The serial section of Figure 6E (visualized with Villanueva-Goldner stain). Mature bone was stained in green, and new bone was stained in red. New bone was gradually being replaced with mature bone (white arrowheads). NB: new bone, CO3Ap: carbonate apatite.

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  Figure 7 EBH reduction rates in 2-stage sinus floor augmentation using various bone substitutes after sinus floor augmentation or implant placement. EBH: elevated bone height, CO3Ap: carbonate apatite. a)Deppe et al. [21]; b)Kim et al. [22]; and c)Hieu et al. [23].

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  Figure 8 New bone formation rates in biopsy specimens from histological evaluation after sinus floor augmentation using autogenous bone, Bio-Oss®, CO3Ap granules. CO3Ap: carbonate apatite. a)Zerbo et al. [24], b)John and Wenz [25], c)Sartori et al. [26], and d)Tadjoedin et al. [27].

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