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| Name | Class |
|---|---|
| Biotechnology Institute IMASD | INDUSTRY |
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This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation.
The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Oss | Active Comparator | the xenograft is of bovine origin where the organic phase has been eliminated. |
|
| calcium phosphate ceramic | Experimental | is a calcium phosphate biomaterial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-Oss | Device | It is a bone substitute of bovine origin |
| |
| calcium phosphate ceramic |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of newly-formed bone | The histomorphometrical analysis of the biopsies taken after 6 months of surgical intervention (time for dental implants insertion) will be performed to calculate the primary outcome | 6 months after surgical intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Bone density | This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing | at baseline and after 6 months of intervention |
| Insertion torque | At the time of implant insertion and initial insertion torque will be registered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Anitua, MD, DDS, PhD | Clinica Eduardo Anitua | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Eduardo Anitua | Vitoria-Gasteiz | Spain |
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| Device |
It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature |
|
| 6 months after surgical intervention |
| Percentage of residual graft | The histological analysis will determine the percentage of residual graft after 6 months of surgery. | 6 months after surgical intervention |
| Pain index | This will evaluate the intensity of pain the patient suffered due to the surgical intervention. | 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention |
| Healing index | This index will evaluate the soft tissue healing. | 7 days, 15 days and 1 month after surgical intervention |
| Infection | Notify the infection of the graft material | 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention |