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Overview of the clinical trial conducted for the Japanese regulatory approval
Purpose of the clinical trial
To evaluate the efficacy and safety of Bonarc™ in bone regeneration, in the field of dentistry and oral surgery, by implanting it into patients with bone defects who require treatment for sinus floor elevation, socket preservation, and cyst and alveolar clefts.
Clinical trial, Explanation of the evaluated contents
- Success rate of dental implant treatment
- Determined to be "good" when all the following 6 criteria were met.
No noticeable infection, no noticeable inflammation, no mobility of the implant body, no noticeable pain, no sensory disorder, and no bone resorption around the implant body. - Maximum torque value for implant body placement
- The maximum torque value of 20N・cm or more of the implant body was defined as "good".
- Biological tissue diagnosis
- The observation of new bone and the absence of histological abnormalities were defined as "good".
- Changes in vertical bone width
- Vertical bone widths before and at 24 weeks after Bonarc™ implantation were measured.
- Computed tomography (CT) value of the regenerated bone
- Using CT images, 150 HU or more was defined as "good".
- Area of the regenerated bone
- Regeneration rate was evaluated based on CT imaging, using the preoperative bone-defect cross-sectional area/cross-sectional area occupied by the regenerated bone at 24 weeks; 0.5 or more was considered "good".
Medical institutions for clinical trial implementation : 9 institutions
Target diseases: Patients requiring any of the following dental or oral surgical procedures:
(1) Patients who undergo maxillary sinus floor elevation for placement of implant body (2) Patients who undergo extraction socket preservation for the placement of implants (3) Patients with a cyst (4) Patients with an alveolar cleft
| Cases to be analyzed (Number of cases) |
Primary endpoint | Secondary endpoint | ||||||
| Evaluation method | Results (Efficacy ratio) |
Value | Evaluation method | Results (Efficacy ratio) |
Value | |||
| Sinus floor elevation | 1 stage | 7 cases | ＜At 4 weeks after superstructure installation＞
Success of dental implant treatment |
85.7％ | 6/7 cases | ＜Immediately after implant body placement＞ (1) ISQ value ＜At the time the superstructure is installed＞ (2) Success of dental implant treatment (3) ISQ value (4) CT value (5) Changes in vertical bone width |
(1) - (2) 100% (3) - (4) - (5) - |
(1) 63.7 ± 12.8 (2) 7/7 cases (3) 69.4 ± 9.6 (4) 266.9 ± 108.4 HU (5) 7.9 ± 2.5 mm |
| 2 stage | 32 cases | ＜At 24 weeks after Bonarc™ implantation (at the time of implant body placement)＞ (1) Maximum torque value* (2) Biological tissue diagnosis |
(1) 21.9% (2) 81.3% (1) and (2) 21.9% |
(1) 16.2 ± 15.7 N･cm (2) - (1) and (2) 7/32 cases |
＜At 24 weeks after Bonarc™ implantation (at the time of implant body placement)＞ (1) ISQ value (2) CT value (3) Changes in vertical bone width |
(1) - (2) 96.7% (3) - |
(1) 50.2 ± 18.4 (2) 295.8 ± 89.1 HU (3) 10.6 ± 3.7 mm |
|
| Socket preservation | 8 cases | (1) 50% (2) 87.5% (1) and (2) 50% |
(1) 18.0 ± 13.6 N･cm (2) - (1) and (2) 4/8 cases |
(1) - (2) 100% (3) - |
(1) 66.0 ± 13.9 (2) 373.4 ± 188.3 HU (3) 7.9 ± 3.2 mm |
|||
| Cyst | 5 cases | ＜At 24 weeks after Bonarc™ implantation＞
CT value |
100% | 427.4 ± 83.3 HU | ＜At 24 weeks after Bonarc™ implantation＞ Bone regeneration ratio |
100% | 0.90 ± 0.11 | |
| Alveolar cleft | 8 cases | 100% | 431.8 ± 115.5 HU | 87.5% | 0.78 ± 0.27 | |||
* "The maximum torque values" were found to vary with existing bone thickness and implant socket making techniques, so an additional test was conducted, "Successful implant treatment."
Additional follow-up was performed on patients who underwent 2-stage sinus floor elevation and socket preservation to evaluate the initial success of implant treatment.
| Cases to be analyzed(Number of cases) | Additional follow-up endpoint | ||||
| Evaluation method | Results(Efficacy ratio) | Value | |||
| Sinus floor elevation | 2 stage | 25 cases | ＜More than 4 weeks after installation of the superstructure＞ Success of dental implant treatment |
96% | 24/25 cases |
| Socket preservation | 6 cases | 100% | 6/6 cases | ||
Reference Kawai et al, Clinical study of octacalcium phosphate and collagen composite in oral and maxillofacial surgery. Journal of Tissue Engineering 2020;11:1-15