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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- the relative amount of mineralised tissue (=newly formed bone plus BO)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- 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.
Arms & Interventions
1
small particles
Intervention: bovine bone mineral particles (Bio-Oss®) (Device)
2
large particles
Intervention: bovine bone mineral particles (Bio-Oss®) (Device)
Outcomes
Primary Outcomes
the relative amount of mineralised tissue (=newly formed bone plus BO)
Time Frame: 20 monthes
Secondary Outcomes
- 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)
Investigators
Lior Shapira
Head of periodontal department
Hadassah Medical Organization