Maxillary Sinus
Conditions
Keywords
Maxillary Sinus, Sinus lifting, Bone graft
Brief summary
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).
Detailed description
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.
Interventions
PROCEDURESinus lift
Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.
PROCEDURESurgical alveolus
Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.
PROCEDUREInorganic bovine bone + newly forming bone
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.
PROCEDUREInorganic bovine bone
Maxillary sinus lift will be done with inorganic bovine bone.
DEVICECollagen membrane
At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
• Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.
Exclusion criteria
* History of periodontal surgery at the area on the last 12 months * Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids) * Pregnant * Smokers * Diabetics * History of head and neck radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone height measured in millimeters using the panoramic radiography reconstructions | Six months | It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners | Six months | 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. |
| Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score | Six months | Quantification of the reactional and reparative phenomena related to cellular and tissue organization on biopsed samples were made using Leahy et al. (2013) score. |
| Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ | Six months | 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. |
Countries
Brazil
Outcome results
None listed