Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sinus Graft |
Device: bovine bone mineral particles (Bio-Oss®) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- the relative amount of mineralised tissue (=newly formed bone plus BO)
- Histology:
- Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.
- Clinical parameters:
- complications during surgery related to the material.
- post-operative complications.
- Max torque for implant insertion.
- short-term implant survival (up to one year post loading)
| Estimated Enrollment: | 8 |
| Study Start Date: | March 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- The patients included in this study are over 18 year old men and women.
- The patient must be a candidate for sinus floor augmentation.
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures.
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.
Exclusion Criteria:
- Pregnant women.
- People who smoke more than 10 cigarettes a day.
- Alcohol and drug abusers.
- People suffering from uncontrolled diabetes, severe osteoporosis, rheumatic arthritis, precancer or neoplastic lesions of oral cavity.
- The patient is nursing.
Contacts and Locations| Contact: Lior Shapira, PhD | 00 972 2 6777826 | shapiral@cc.huji.ac.il |
| Contact: Hadas Lemberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
| Israel | |
| Hadassah Medical Organization | |
| Jerusalem,, Israel | |
| Principal Investigator: | Lior Shapira, PhD, DMD | department of periodontology, Hadassah Medical Organization |
| Study Director: | Tali Chackartchi, DMD | department of periodontology,Hadassah Medical Organization |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00426322 History of Changes |
| Other Study ID Numbers: | shapiral-HMO-CTIL |
| Study First Received: | January 23, 2007 |
| Last Updated: | January 23, 2007 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
|
maxillary sinus augmentation bone graft bovine bone mineral dental implants |
ClinicalTrials.gov processed this record on June 17, 2013