Sinus Graft
Conditions
Keywords
maxillary sinus augmentation, bone graft, bovine bone mineral, dental implants
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, large1-2 mm, and small0.25-1 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.
Interventions
DEVICEbovine bone mineral particles (Bio-Oss®)
bovine bone mineral particles used for sinus augmentation prior to dental implant placement
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the relative amount of mineralised tissue (=newly formed bone plus BO) | 20 monthes |
Secondary
| Measure | Time frame |
|---|---|
| Clinical parameters: | 32 monthes |
| complications during surgery related to the material. | 20 monthes |
| Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue. | 20 monthes |
| Max torque for implant insertion. | 20 monthes |
| short-term implant survival (up to one year post loading) | 32 monthes |
| post-operative complications. | 20 monthes |
Countries
Israel
Outcome results
None listed