Completed

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

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What is being tested

bovine bone mineral particles (Bio-Oss®)

Device
Who is being recruted

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2007
See protocol details

Summary

Principal SponsorHadassah Medical Organization
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleEfficacy of Sinus Floor Augmentation Using Large (1-2mm) or Small (0.25-1mm) Bovine Bone Mineral Particles (Bio-Oss®): A Comparative Histomorphometric Clinical Study
NCT00426322
Principal SponsorHadassah Medical Organization
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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.
5 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
small particles

Group II

Active Comparator
large particles

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hadassah Medical Organization

Jerusalem, IsraelOpen Hadassah Medical Organization in Google Maps
CompletedOne Study Center