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| Name | Class |
|---|---|
| Universidade do Porto | OTHER |
| Dentsply Sirona Implants and Consumables | INDUSTRY |
| Tecnoss OsteoBiol | UNKNOWN |
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Previous in a randomized way, it will be performance 12 bilateral sinus lift with autologous bone in one side and the in other with xenograft material. After 6 mouths we will place 1 to 3 implants in each side and analyse the survival rate and possibles differences related to; prosthesis failure; biological and prosthetic complications; peri-implant marginal bone level changes.
The study will be performance in 12 patients submitted to a bilateral sinus lift procedure.
Six months after the bilateral sinus lifting performed in a randomly way, using as graft materials (100% of autologous bone graft or 100% of xenograft), will be placed 1 to 3 implants in each maxillary sinus.
Wait more six months to expose the implant. At the end of 13 months after implant placement it should be in charge.
Implant placement (6 months after sinus lift procedure):
Post-implant placement instructions:
Abutment connection (6 months after implant placement):
Post-abutment connection instructions:
Prosthetic phase:
Maintenance:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| survival rate autologous bone | Active Comparator | dental implant placement in the previous sinus lift side with autologous bone; dental implant placement in the previous sinus lift side with xenograft material side; |
|
| survival rate axenograft material | Active Comparator | dental implant placement in the previous sinus lift side with xenograft material side; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survival rate dental implant (OsseoSpeed™) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological and histomorphological analysis | Histological and histomorphological analysis of the bone graft | 6 mounths |
| radiological analysis | Comparation of the bone gain in a radiological analysis (initial and at 6 months) | 6 mounths |
| Clinical evaluation - questionary | questionary about patient preference treatment | 6 mounths |
| Implant failure | implant mobility assessed manually with the removed prosthesis and/or any infection dictating implant removal. Assessments will be done at delivery of the provisional and definitive prostheses, 1, 3 and 5 years of loading by tightening the abutment screws with the removed prostheses. | up to 5 years of loading |
| Prosthesis failure | when prosthesis placement will not be possible due to implant failure or secondary to implant failure. | up to 5 years of loading |
| Peri-implant marginal bone level changes | Peri-implant marginal bone level changes assessed on periapical radiographs taken with the paralleling technique at implant placement, at initial prosthetic loading, 1 and 5 years follow-up in function. The distance between marginal bone level and implant/abutment junction, approximated to half mm, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at patients level and then at group level. | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Correia, DDS, Msc, PhD | Universidade do Porto | Principal Investigator |
| Ricardo Faria Almeida, DDS, Msc, PhD | Universidade do Porto | Study Director |
| Antonio Campos Felino, DDS, PhD | Universidade do Porto | Study Chair |
| Sonia Gouveia, Phd | Instituto de Engenharia Eletrónica e Informática de Aveiro (IEETA/UA) and Centro de I&D em Matemática e Aplicações (CIDMA/UA), Universidade de Aveiro (UA), Portugal | Study Chair |
| Daniel H Pozza, DDS, PhD | Departamento de Biomedicina da Faculdade de Medicina, and Faculdade de Ciências da Nutrição e Alimentação, and I3s, Universidade do Porto, Porto, Portugal. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Porto, Faculty of Dental Medicine | Porto | Porto District | 4200-256 | Portugal |
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| Label | URL |
|---|---|
| Related Info | View source |
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randomizes split month trial:
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Seal envelops, codification of the side and patient and independent blind assessors
| Biological complications |
Biological complications (number and type). Particular attention will be used to assess possible sinus pathologies. |
| up to 5 years |
| Prosthetic complications | Prosthetic complications (number and type). | up to 5 years |