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The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBR membrane | Device | GBR procedure is a technique often used in conjunction with dental implants to enhance the success and stability of the implant. This technique involves using barrier membranes to protect the bone graft or defect site from the rapid proliferation of surrounding soft tissues. In this clinical investigation resorbable, collagen membrane will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of collagen membrane's - efficacy and safety. | Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results. | 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Complication rate assessed as the ratio patients with any complication to all patients. | 7 days and 6 months after intervention |
| Change in bone dimensions | % change in horizontal bone dimensions at three subcrestal levels assessed via CBCT. |
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Inclusion Criteria (among others):
Exclusion Criteria (among others):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pure Clinical | Contact | + 48 | MDsafety@pureclinical.eu |
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| Baseline, 6 and 12 months after intervention |
| VAS scale | Scale VAS for pain, swelling, bleeding. VAS scale will be used to assess satisfaction of the intervention. | On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention. |
| Assessment of collagen membrane's - safety. | Number of (S)AEs. | From the beginning till the end. |