Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.
- Conditions
- Sinus Graft
- Registration Number
- NCT00426322
- Lead Sponsor
- Hadassah Medical Organization
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method the relative amount of mineralised tissue (=newly formed bone plus BO) 20 monthes
- Secondary Outcome Measures
Name Time Method 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. 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
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem,, Israel
Hadassah Medical Organization🇮🇱Jerusalem,, Israel