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

Sinus Graft Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426322
• Other study ID #: shapiral-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: January 23, 2007
• Last updated: September 9, 2013
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2013
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinus Graft

Intervention

Device:
• bovine bone mineral particles (Bio-Oss®)
bovine bone mineral particles used for sinus augmentation prior to dental implant placement

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem,

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the relative amount of mineralised tissue (=newly formed bone plus BO)		20 monthes	No
Secondary	Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.		20 monthes	No
Secondary	Clinical parameters:		32 monthes	No
Secondary	complications during surgery related to the material.		20 monthes	No
Secondary	post-operative complications.		20 monthes	No
Secondary	Max torque for implant insertion.		20 monthes	No
Secondary	short-term implant survival (up to one year post loading)		32 monthes	No