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
  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®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • the relative amount of mineralised tissue (=newly formed bone plus BO) [ Time Frame: 20 monthes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426322

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

No publications provided

Responsible Party: Lior Shapira, Head of periodontal department, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00426322     History of Changes
Other Study ID Numbers: shapiral-HMO-CTIL
Study First Received: January 23, 2007
Last Updated: September 9, 2013
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 July 23, 2014