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
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 April 16, 2014