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

Not Applicable

Completed

• Conditions: Sinus Graft
• Interventions: Device: bovine bone mineral particles (Bio-Oss®)

• 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.

Study Timeline

• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Study Start: 2007-03
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bovine bone mineral particles (Bio-Oss®)	small particles
2	bovine bone mineral particles (Bio-Oss®)	large particles

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