Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 23, 2007 | ||||||||
| Last Updated Date | January 23, 2007 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
the relative amount of mineralised tissue (=newly formed bone plus BO) | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral. | ||||||||
| Official Title ICMJE | Efficacy of Sinus Floor Augmentation Using Large (1-2mm) or Small (0.25-1mm) Bovine Bone Mineral Particles (Bio-Oss®): A Comparative Histomorphometric Clinical Study | ||||||||
| Brief Summary | The aim of this clinical study is to compare the amount of newly formed bone after bone augmentation with Bio-Oss® (BO) 0.25-1 mm vs. Bio-Oss® (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. |
||||||||
| Detailed Description | the use of bovine bone mineral particles (Bio-Oss®)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-Oss® (BO) with particle size of 0.25-1 mm vs. Bio-Oss® (BO)with particle size of 1-2 mm. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Sinus Graft | ||||||||
| Intervention ICMJE | Device: bovine bone mineral particles (Bio-Oss®) | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 8 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00426322 | ||||||||
| Other Study ID Numbers ICMJE | shapiral-HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | January 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||