Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral. - Full Text View

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00426322

Purpose

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.

Condition	Intervention
Sinus Graft	Device: bovine bone mineral particles (Bio-Oss®)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Minerals

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

the relative amount of mineralised tissue (=newly formed bone plus BO)

Secondary Outcome Measures:

Histology:
Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.
Clinical parameters:
complications during surgery related to the material.
post-operative complications.
Max torque for implant insertion.
short-term implant survival (up to one year post loading)

Estimated Enrollment:	8
Study Start Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426322

Contacts

Contact: Lior Shapira, PhD	00 972 2 6777826	shapiral@cc.huji.ac.il
Contact: Hadas Lemberg, PhD	00 972 2 6777572	lhadas@hadassah.org.il

Locations

Israel
Hadassah Medical Organization
Jerusalem,, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:	Lior Shapira, PhD, DMD	department of periodontology, Hadassah Medical Organization
Study Director:	Tali Chackartchi, DMD	department of periodontology,Hadassah Medical Organization

More Information

No publications provided

Study ID Numbers:	shapiral-HMO-CTIL
Study First Received:	January 23, 2007
Last Updated:	January 23, 2007
ClinicalTrials.gov Identifier:	NCT00426322 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

maxillary sinus augmentation
bone graft
bovine bone mineral
dental implants

ClinicalTrials.gov processed this record on November 27, 2009