How can you choose the rod and discs?

Please choose the type according to clinical convenience.

Is Bonarc_™ flexible?

Bonarc_™ becomes flexible by absorbing blood and/or physiological saline. Bonarc_™ becomes softer and can follow curved surfaces after the absorption.

Can autologous bone or other bone graft materials apply together with Bonarc_™?

We havenʼt confirmed this application in our clinical trial.

Does Bonarc_™ have any hemostatic effects?

When Bonarc_™ is implanted, Bonarc_™ absorbs a certain amount of blood; however, its hemostatic effect has not been confirmed.

How should we treat the scars after implantation?

We recommend to close the scars.

How many months after implantation of Bonarc_™ can we introduce implant bodies?

In our clinical trial, an implant body was introduced 6 months after Bonarc_™ implantation in the maxillary sinus floor elevation (late implant placement) and extraction socket preservation. The success rate of the implants including implant body movement at 4 weeks after superstructure placement were 96.0% and 100%, respectively. The success rate of immediate implant placement was 85.7%.

Why are the implantation torque values low in your clinical trial?

The following 2 points are possible contributing factors:
1. The existing bone thickness is thinner.
2. As a result, most of Bonarc_™ was degraded and absorbed during the 6-month period before the placement of the implant, only regenerated bone was left. As an additional follow-up, the success rate of the implant, including implant body movement, was evaluated at 4 weeks after the placement of the superstructure. The effectiveness was 96.0% or higher.

Is Bonarc_™ radiopaque?

Because Bonarc_™ is not radiopaque, it is difficult to confirm the state of implantation and installation with its dosage during regular medical treatment and diagnosis. The regenerated bone can be easily confirmed because the newly formed bone is radiopaque.

How about prognosis (after implant body introduction)?

Prognostic follow-up is being continued for approximately 30 of 47 in our clinical trial cases whose progress was reported at the Japanese conference, and no critical issues have been reported so far. In both two cases of clinical studies conducted before our clinical trial, approximately 6 and 7 years have passed since the implantation of Bonarc_™. The prognosis is good, and no critical issues have been reported (2019, as of the time of the Japanese conference).

What are alveolar cleft outcomes with Bonarc_™ ?

In our clinical trial, all of the 8 cases with Bonarc_™ showed newly formed bone on the bone defects, the eruption and movement of permanent teeth. The timing for the initiation of orthodontics was equivalent to that for , autograft bone surgery.

What types of adverse events occurred in your clinical trial?

The treatment was stopped in 2 of 62 cases during the trial due to device protrusion In each case, the cause was likely an reopen due to insufficient suturing of the scar.No causal relationships between the devices and the events were determined.
For more information on the adverse events, please visit our clinical trial page.

Does the newly formed bone with Bonarc_™ in the maxillary sinus floor elevation have sufficient stiffness for dental implant placement.

In our clinical trial, 78.1% of patients who underwent sinus floor elevation in 2nd stage procedures had < 20 N-cm of a maximum torque value on the implant placement at the 24-week follow-up. However, additional follow-up evaluations revealed that the success rate of implant treatment, including implant body movement, was 96% at 4 weeks after the placement of the superstructure.

Is vertical bone creation possible with Bonarc_™ alone?

Although no clinical study has been undertaken for such an application, a canine mandibular defect model was developed by a research group at the Tohoku University which is the original researching organization of this device using a combination of OCP/Col (a compound equivalent to Bonarc_™) and + titanium mesh, and vertical bone augmentation was confirmed near the alveolar bone crest.

The manufacturer recommends closing the wound after Bonarc_™ implantation; however, in actual medical practice, it is difficult to achieve closure in all cases of extraction socket preservation. Does it have to be completely closed?

In the clinical trial, the protocol was set as closing the scar. In 2 cases of extraction socket preservation in which the wounds were not completely closed, Bonarc_™ leaked out at a later date, and both cases were discontinued as per the trial protocol. There are no clinical data on open wounds at this time.

How many materials have been remained after 6 months of Bonarc_™ implantation in your clinical trial?

The results of the biopsy after 6 months of Bonarc_™ implantation in the sinus floor elevation in the 2nd stage procedure showed that the new bone generation rate was approximately 50%, fibrous tissue was 40%, and others were 10%. Therefore, we believe that the residual percentage of Bonarc_™ should not exceed 10%.

Is the volume of newly formed bone the same as the implanted volume of Bonarc_™?

According to our clinical investigatorʼs comments, 6 months after Bonarc_™ implantation, perpendicular bone spreading possibly decreased by 10%–20% in height immediately after Bonarc_™ implantation in the case of sinus floor elevation in the 2nd stage procedure.

In your clinical trial, after Bonarc_™ implantation, what structure does the new bone near the boundary with the autologous bone show?

The biopsy after 6 months of Bonarc_™ implantation in the trial indicates that the Bonarc_™ implanted site has a similar structure to the autologous bone. According to our clinical investigatorʼs comment, "In some cases, it can be difficult to distinguish between the original bone and the newly formed bone."

When Bonarc_™ and a membrane are applied together, is there any different compatibility by the membrane material or by its adsorptive or nonadsorptive capability? Is there a tendency for more fibrous tissue to be produced where the membrane and the device come into contact?

In animal studies that evaluated the use of Bonarc_™ + and titanium mesh in combination, there were no reports of particularly high levels of fibrous tissue.

The maximum torque on the implant body 6 months after Bonarc_™ implantation is not enough since low vertical bone height and the regenerated soft bone by Bonarc_™ occupies a lot on the defect. Can the regenerated bone mature and harden after the device implantation?

As far as the CT(Computed tomography) and ISQ(Implant stability quotient) values from 6 months to 1 year after Bonarc_™ implantation show, the regenerated bone seems to be hardened.

When an implant body is drilled on the regenerated part with Bonarc_™, is it necessary to use a special method?

No special method is needed; please follow your conventional method.

To which cysts was Bonarc_™ applied in your clinical trial?

In our clinical trial, Bonarc_™ was applied to periodontal cysts and jaw bone cysts.

Up to which size of cysts can Bonarc_™ be used for?

In our clinical trial, Bonarc_™ was applied to 5 cysts ranging from 5 to 25 mm in diameter, and the bone regeneration in all the cases have met our evaluation criteria.

Can Bonarc_™ be applied on patients being treated for malignant tumors?

In our clinical trial, patients with malignant tumors were not included. Therefore, there are currently no clinical data available to verify that.