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

September 9, 2013 updated by: Lior Shapira, Hadassah Medical Organization

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem,, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
small particles
Device: bovine bone mineral particles (Bio-Oss®)
bovine bone mineral particles used for sinus augmentation prior to dental implant placement
Other Names:
  • bovine bone mineral particles (Bio-Oss®) small particles
  • bovine bone mineral particles (Bio-Oss®) large particles
Active Comparator: 2
large particles
Device: bovine bone mineral particles (Bio-Oss®)
bovine bone mineral particles used for sinus augmentation prior to dental implant placement
Other Names:
  • bovine bone mineral particles (Bio-Oss®) small particles
  • bovine bone mineral particles (Bio-Oss®) large particles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the relative amount of mineralised tissue (=newly formed bone plus BO)
Time Frame: 20 monthes
20 monthes

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.
Time Frame: 20 monthes
20 monthes
Clinical parameters:
Time Frame: 32 monthes
32 monthes
complications during surgery related to the material.
Time Frame: 20 monthes
20 monthes
post-operative complications.
Time Frame: 20 monthes
20 monthes
Max torque for implant insertion.
Time Frame: 20 monthes
20 monthes
short-term implant survival (up to one year post loading)
Time Frame: 32 monthes
32 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 23, 2007

First Submitted That Met QC Criteria

January 23, 2007

First Posted (Estimate)

January 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 9, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • shapiral-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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