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

This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, January 2007

Sponsored by: 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®)

MedlinePlus related topics:   Minerals   

U.S. FDA Resources

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

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


Study ID Numbers:   shapiral-HMO-CTIL
First Received:   January 23, 2007
Last Updated:   January 23, 2007
ClinicalTrials.gov Identifier:   NCT00426322
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 September 23, 2008




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