Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.

Hadassah Medical Center

Status

Completed

Conditions

Sinus Graft

Treatments

Device: bovine bone mineral particles (Bio-Oss®)

Study type

Interventional

Funder types

Other

Identifiers

NCT00426322

shapiral-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.