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

NCT ID: NCT00426322

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Sinus Graft

Keywords

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maxillary sinus augmentation bone graft bovine bone mineral dental implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

small particles

Group Type ACTIVE_COMPARATOR

bovine bone mineral particles (Bio-Oss®)

Intervention Type DEVICE

bovine bone mineral particles used for sinus augmentation prior to dental implant placement

2

large particles

Group Type ACTIVE_COMPARATOR

bovine bone mineral particles (Bio-Oss®)

Intervention Type DEVICE

bovine bone mineral particles used for sinus augmentation prior to dental implant placement

Interventions

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bovine bone mineral particles (Bio-Oss®)

bovine bone mineral particles used for sinus augmentation prior to dental implant placement

Intervention Type DEVICE

Other Intervention Names

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bovine bone mineral particles (Bio-Oss®) small particles bovine bone mineral particles (Bio-Oss®) large particles

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Lior Shapira

Head of periodontal department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lior Shapira, PhD, DMD

Role: PRINCIPAL_INVESTIGATOR

department of periodontology, Hadassah Medical Organization

Tali Chackartchi, DMD

Role: STUDY_DIRECTOR

department of periodontology,Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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shapiral-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id