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The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. It will be recruited for this study individuals 25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The volume of bone tissue will be evaluated by computerized tomography obtained at baseline examination and 6 months after surgery. After this period, biopsies of hard tissue will be obtained during implant placement for histologic and histomorphometric analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane |
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| Control group | Active Comparator | Maxillary sinus lift with inorganic bovine bone + collagen membrane |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinus lift | Procedure | Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bone height measured in millimeters using the panoramic radiography reconstructions | It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners | On the surface and around the particles of the materials with the newformed reactive tissue, it was analyzed the presence and absence of the following tissue and reactive cellular elements: granulation tissue, newly formed blood vessels, fibroblasts, osteoblasts and mineralized bone matrix, foreign body type granuloma, macrophages, inflammatory multinucleated giant cells. |
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Inclusion Criteria:
• Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana CP Sant'Ana, PhD | Bauru School of Dentistry - University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bauru School of Dentistry - University of Sao Paulo | Bauru | São Paulo | 17012-901 | Brazil |
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| Surgical alveolus | Procedure | Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region. |
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| Inorganic bovine bone + newly forming bone | Procedure | Maxillary sinus lift will be done with inorganic bovine bone associated with newly forming bone. The newly forming bone will be collected from surgical alveolus previous prepared. |
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| Inorganic bovine bone | Procedure | Maxillary sinus lift will be done with inorganic bovine bone. |
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| Collagen membrane | Device | At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus. |
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| Six months |
| Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score | Quantification of the reactional and reparative phenomena related to cellular and tissue organization on biopsed samples were made using Leahy et al. (2013) score. | Six months |
| Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ | The tissue sections were captured with 4x and 10x objective and images were recorded and later analyzed in the ImageJ software. The proportions of vital bone, cortical bone, medullary bone, remnant non-vital particles and connective tissue were quantified separately and expressed as percentages. | Six months |