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Clinical Trial of RED-188 Supplementation Treatment for Maxillary Sinus Floor Lifting

RED-188 Clinical Trial

24

The mean age of the patients was 55.7 years, the mean weight was 61.95 kg, the mean height was 164.41 cm, and 47.8% of the patients were male.

As this was an open-label study, 23 patients (24 teeth) were enrolled and assigned to either simultaneous implantation (6 patients (6 teeth)) or waiting implantation (17 patients (18 teeth)) based on the distance from the alveolar crest to the floor of the maxillary sinus (vertical remaining bone volume). In each assignment, one patient (one tooth) was discontinued after implantation of the investigational device, so the final analysis was performed using the simultaneous implantation (5 patients (5 teeth)) and waiting implantation (16 patients (17 teeth)).

Adverse events for which a causal relationship to the investigational device could not be denied included four cases of "moderate to severe" "dental restoration failure," as well as one case each of "paranasal sinus mucosa thickening," "oral herpes," "wound inflammation," and "oropharyngeal pain" that were "mild," but all were non-serious. No adverse events leading to death were reported, and a causal relationship to the investigational device was denied for other serious adverse events. Additionally, no malfunctions were reported in any cases.

<Primary Evaluation> In the main analysis of the 24 FAS-evaluated teeth, the success rate based on the implant treatment success criteria 4 weeks after the placement of the superstructure was 91.7% (22 out of 24 were successful), with a precise two-sided 95% confidence interval of 73.0-99.0%, with the lower limit exceeding 70%. However, of the 22 teeth evaluated as successful, 3 were cases of deviation that fell under the prohibited combination therapy, and all of them had been implanted using a combination of a competitor's product and autologous bone. Taking this into consideration, a secondary analysis was conducted on the 20 PPS-evaluated teeth, excluding the 4 teeth that were deviations from the 24 FAS-evaluated teeth that were subject to prohibited concomitant therapy.The results showed that the success rate for all evaluated teeth was 95.0% (19 out of 20 were successful), with an exact two-sided 95% confidence interval of 75.1-99.9%, and the lower limit of the exact two-sided 95% confidence interval was 70% or higher, confirming the clinical usefulness of this investigational device. <Secondary evaluation> The success rate of maxillary sinus floor augmentation by surgical method showed a similar trend, with a success rate of 83.3% for all evaluated teeth. In addition, although the degree of bone reconstruction was difficult to judge accurately due to the large variation in values, it was judged to be showing a trend toward improvement, and it was confirmed that the implant stability rate was high relative to the bone regeneration improvement rate.

In the primary analysis of the 24 FAS-equipped evaluation teeth, which was the primary evaluation item, the lower limit of the exact two-sided 95% confidence interval for the success rate of all evaluated teeth 4 weeks after placement of the superstructure was 70% or higher.In addition, the lower limit of the exact two-sided 95% confidence interval for the success rate of the PPS-equipped evaluation teeth was 70% or higher, confirming the clinical usefulness of this investigational device.

May. 01, 2025

May. 01, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2032210306

Nkajima Takehiko

HOYA Technosurgical Corpolation

4-28-4 Yotsuya, Shinjuku-Ku, Tokyo

takehiko.nakajima@pc.hoya.co.jp

Nakajima Takehiko

HOYA Technosurgical Corpolation

4-28-4 Yotsuya, Shinjuku-Ku, Tokyo

+81-353691702

takehiko.nakajima@pc.hoya.co.jp

Complete

Sept. 13, 2021

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

Patients who meet all of the following criteria will be included in the study:
1. Age 20 years or older and younger than 80 years at the time of obtaining informed consent
2. Patients requiring bone augmentation with bone prosthesis during maxillary sinus floor elevation for implant body placement in the maxillary molar region
3. Patients whose general condition is stable and who can be operated on
4. Patients who are able to obtain written informed consent by themselves

Patients who meet any of the following criteria should not be eligible for the study:
1. Patients with the following general conditions
- Severe liver / kidney disorders and heart disease
- Malignant tumor (combined or with a history within 5 years)
- Severe blood disease
-Severe diabetes (diabetes with poor control even after drug therapy *)
* Fasting blood glucose: 140 mg / dL excess, ketone bodies (+), HbA1c: 6.9% (NGSP value) or higher
- Requires dialysis therapy
- Calcium metabolism disorder
- Bone target hormone metabolism disorder
- Immunodeficiency
2. Patients with a history of allergy to each component of the investigational device (collagen, hydroxyapatite)
3. Patients with drug allergy
4. Patients receiving drugs for osteoporosis (e.g., bisphosphonates)
5. Patients receiving antithrombotic drugs (e.g., Warfarin)
6. Patients receiving immunosuppressive therapy (patients receiving immunosuppressive drugs after organ transplantation, patients with severe collagen disease, etc.)
7. Smoker
8. Pregnant women or women who wish to become pregnant or breastfeeding during the study period.
9. Patients who have participated in other clinical trials within 1 year before the replacement of the investigational device
10. Other patients who are judged by the principal investigator or the subinvestigator to be ineligible for the study.

Both

Inplant

For patients undergoing maxillary sinus floor elevation, an amount of dental collagen-based bone regeneration material (RED-188) is placed to fill the maxillary sinus as a bone replacement material, and implants are performed after bone regeneration.

Success Rate Based on Implant Treatment Success Criteria at 4 Weeks After Superstructure Placement.

1) Success rate based on Implant Treatment Success Evaluation Criteria before superstructure placement (at 24 weeks after investigational device replacement)
2) Trends in CT values immediately after surgery, 12 weeks after surgery, and 24 weeks after surgery for investigational device replacement (maxillary sinus floor elevation).
3) Improvement rate of bone regeneration based on the criteria for improvement in bone regeneration at 24 weeks after the replacement of the investigational device (Hounsfield unit: HU). 4) Changes in the amount of vertically residual bone before surgery, immediately after surgery, 12 weeks after surgery, and 24 weeks after surgery for the replacement of the investigational device (floor elevation of the maxillary sinus)
5) Percentage change in vertical residual bone volume before surgery and at 24 weeks after investigational device replacement
6) Implant stability rate based on the acceptance criteria for implant stability according to the ISQs (Implant stability quotient: implant stability index) immediately after implant placement and before superstructure placement (at 24 weeks after investigational device replacement)
7) Improvement rate based on evaluation criteria for improvement in bone regeneration by maximum torque value before superstructure placement (at 24 weeks after investigational device replacement)
8) Improvement rate based on evaluation criteria for improvement in bone regeneration by biopsy diagnosis before superstructure placement (at 24 weeks after investigational device replacement) [Evaluation of waitlist implantation only]
Safety Evaluation
1) Adverse events (including confirmation of abnormal laboratory changes)
2) Failure

+81-3-3261-5511

May. 26, 2021

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