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The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.
Synergoss is a granulated bone graft intended for use in dental applications. It is composed of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on the ceramic granule surface.
The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS, a synthetic dental graft coated with collagen. For this observational study, we will enroll patients that already received a surgical intervention for sinus augmentation/ socket preservation by means of SYNERGOSS to maintain and regenerate bone before installation of endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just before they receive the surgery for the installation of endosseous titanium implants, about 24 weeks after the first surgery for the implant of SYNERGOSS.
The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen clinical benefit as declared in the Technical File.
The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those declared in the Technical File.
The study design is a
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | The subjects enrolled in this CI just received dental grafting by the device under evaluation and in any case will be subject to the same procedures foreseen for this CI for the dental implant surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| synergoss Pxx | Device | dental grafting |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Bone Volume total (%BV) | The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of total bone volume as compared to the specimen volume | 4-6 months |
| • graft Volume (%graft) | The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of residual, non absorbed graft volume as compared to the specimen volume | 4-6 months |
| • vital bone (%VB). | The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of vital, new formed bone volume as compared to the specimen volume | 4-6 months |
| • device radiologic density (in a qualitative scale ranging from 1 to 4) | the radiological density is visually evaluated by the investigator | 4-6 months |
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Inclusion Criteria:
• Received in the past 16-24 weeks a bone graft for sinus lift or socket preservation with the ID
Exclusion Criteria:
• Uncontrolled Diabetes
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The subjects enrolled in this CI just received dental grafting and in any case will be subject to the same procedures foreseen for this CI for the dental implant surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| marco morra, dr | Contact | mmorra@nobilbio.it |
| Name | Affiliation | Role |
|---|---|---|
| Ruggero Rodriguez y Baena | POLICLINICO S. MATTEO - PAVIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S. Matteo - Pavia | Recruiting | Pavia | PV | 27100 | Italy |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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vital bone specimen sampled during surgery for dental implant placement