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Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla.
Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. clinical study of 20 patients 13 in OSSIX Bone group 13 in Bio-Oss Collagen group all patients requiring a regenerative procedure (sinus lift) having less than 3mm of residual bone height (RBH) with the impossibility to place the implants at the time of regenerative proc 6 months follow up for the first endpoint. (collection of the histological sample) 12 months follow up - long term clinical evaluation. tests performed: Cone Beam Computed Tomography (CBCT), clinical evaluation, X-ray
Visit 1 - Screening Visit - preoperative visit (informed consent, dental mouth cleaning, CBCT, intraoral scanning).
Visit 2 - Baseline visit - T0 (surgical procedure) Sinus elevation with OSSIXĀ® Bone or Bio-OssĀ® Collagen, periapical x-ray, intraoral photo with microscope.
Visit 3 - Follow up visit - 14 days - suture removal, clinical evaluation and patient satisfaction questionnaire.
Visit 4 - Follow up visit - 180days (One week before) Cone Beam Computed Tomography (CBCT), Dental mouth cleaning, intraoral scanning.
(Second surgery) implant site preparation and histological sample collection, implant placement, insertion torque value, implant stability, peri-apical x-ray, intraoral scanning and photography.
Visit 5 - Follow up visit - 194 days suture removal and clinical evaluation. Visit 6 - Follow up visit - 270 days Implant stability, clinical examination, definitive restoration and periapical x-ray Visit 7- Follow up visit - 365 days Implant stability, peri-apical x-ray, definitive restoration, Cone Beam Computed Tomography (CBCT), intraoral scanning and picture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSSIX Bone | Experimental | OSSIXĀ® Bone in the maxillary sinus elevation. |
|
| Bio-Oss collagen | Active Comparator | Bio-Oss Collagen in the maxillary sinus elevation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maxillary sinus elevation through transcrestal approach using OSSIXĀ® Bone | Procedure | After a careful radiologic analysis, using a surgical guide, maxillary sinus elevation through transcrestal access to sinus mucosa was achieved. The elevation of the maxillary sinus mucosa was performed through micro-elevators and graft material was inserted. |
| Measure | Description | Time Frame |
|---|---|---|
| histological analysis | samples were collected and histologically and immunohistologically analyzed | 6 months after graft insertion |
| Measure | Description | Time Frame |
|---|---|---|
| radiological analyis | preoperatively Cone Beam Computed Tomography (CBCT) was compared to 12 months CBCT. The volume of bone regeneration was measured by performing a semi-automatic segmentation using a specific segmentation software (3D Slicer) and measured in mm3. | 12 months |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studi Odontoiatrici Luigi Canullo | Roma | RM | 00100 | Italy |
data will be shared if required
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controlled clinical investigation
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assessors analyzed blindly receiving anonymized bone samples and CBCT
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