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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00426322
First received: January 23, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 23, 2007
January 23, 2007
March 2007
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the relative amount of mineralised tissue (=newly formed bone plus BO)
Same as current
No Changes Posted
  • 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)
Same as current
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Not Provided
 
Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.
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.

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.

Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sinus Graft
Device: bovine bone mineral particles (Bio-Oss®)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
8
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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.
Both
18 Years and older
Yes
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
Israel
 
NCT00426322
shapiral-HMO-CTIL
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Hadassah Medical Organization
Not Provided
Principal Investigator: Lior Shapira, PhD, DMD department of periodontology, Hadassah Medical Organization
Study Director: Tali Chackartchi, DMD department of periodontology,Hadassah Medical Organization
Hadassah Medical Organization
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP