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This is a prospective, multicentre, parallel-group, randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device, and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. |
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| Standard of care arm | Active Comparator | The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places standard of care device and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tooth extraction and GBR procedure | Device | The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device (first arm) or standard of care (second arm) and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure. | A new bone formation assesses via histomorphometric evaluation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of (serious) adverse events (S)AEs. | Number of (S)AEs | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indywidualna Praktyka Stomatologiczna Marek Śmielecki | Gniezno | 62-200 | Poland | |||
| Medicare |
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| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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|
| Mińsk Mazowiecki |
| 05-300 |
| Poland |
| Stomatologia Niteckie Sp. z o.o. | Tychy | 43-100 | Poland |
| Rafał Dobrakowski Dentysta | Wroclaw | 53-030 | Poland |