Maxillary Sinus Clinical Trial
Official title:
Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation
Verified date | January 2018 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 16 |
Est. completion date | June 30, 2013 |
Est. primary completion date | June 1, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Bauru School of Dentistry - University of Sao Paulo | Bauru | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | Six months | |
Secondary | 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 | |
Secondary | 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 |
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