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The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-OssĀ® (BO) 0.25-1 mm vs. Bio-OssĀ® (BO) 1-2 mm in the sinus floor augmentation procedure bilaterally in 8 patients.
Hypothesis:
There is no difference in the relative amount of newly formed bone plus BO between the large (1-2 mm) and small (0.25 - 1 mm) granules.
the use of bovine bone mineral particles (Bio-OssĀ®)in sinus floor augmentation is well established. bovine bone mineral is an oseoconductive material which serves as a space maintainer and a scaffold for bone augmentation. the commercial product is manufactured in two different particles sizes, "large"1-2 mm, and "small"0.25-1 mm.
Comparison: the histologic characteristics of augmented bone after the use of Bio-OssĀ® (BO) with particle size of 0.25-1 mm vs. Bio-OssĀ® (BO)with particle size of 1-2 mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | small particles |
|
| 2 | Active Comparator | large particles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bovine bone mineral particles (Bio-OssĀ®) | Device | bovine bone mineral particles used for sinus augmentation prior to dental implant placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| the relative amount of mineralised tissue (=newly formed bone plus BO) | 20 monthes |
| Measure | Description | Time Frame |
|---|---|---|
| Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue. | 20 monthes | |
| Clinical parameters: | 32 monthes | |
| complications during surgery related to the material. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lior Shapira, PhD, DMD | department of periodontology, Hadassah Medical Organization | Principal Investigator |
| Tali Chackartchi, DMD | department of periodontology,Hadassah Medical Organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | Israel |
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| 20 monthes |
| post-operative complications. | 20 monthes |
| Max torque for implant insertion. | 20 monthes |
| short-term implant survival (up to one year post loading) | 32 monthes |