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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lior Shapira, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00426322
First received: January 23, 2007
Last updated: September 9, 2013
Last verified: September 2013

January 23, 2007
September 9, 2013
March 2007
December 2008   (final data collection date for primary outcome measure)
the relative amount of mineralised tissue (=newly formed bone plus BO) [ Time Frame: 20 monthes ] [ Designated as safety issue: No ]
the relative amount of mineralised tissue (=newly formed bone plus BO)
Complete list of historical versions of study NCT00426322 on ClinicalTrials.gov Archive Site
  • Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue. [ Time Frame: 20 monthes ] [ Designated as safety issue: No ]
  • Clinical parameters: [ Time Frame: 32 monthes ] [ Designated as safety issue: No ]
  • complications during surgery related to the material. [ Time Frame: 20 monthes ] [ Designated as safety issue: No ]
  • post-operative complications. [ Time Frame: 20 monthes ] [ Designated as safety issue: No ]
  • Max torque for implant insertion. [ Time Frame: 20 monthes ] [ Designated as safety issue: No ]
  • short-term implant survival (up to one year post loading) [ Time Frame: 32 monthes ] [ Designated as safety issue: No ]
  • 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)
Not Provided
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sinus Graft
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: 1
    small particles
    Intervention: Device: bovine bone mineral particles (Bio-Oss®)
  • Active Comparator: 2
    large particles
    Intervention: Device: bovine bone mineral particles (Bio-Oss®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2008
December 2008   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
Israel
 
NCT00426322
shapiral-HMO-CTIL
Not Provided
Lior Shapira, Hadassah Medical Organization
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
September 2013

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