Clinical trial NCT00426322: Efficacy of Sinus Floor Augmentation Using Large or Small Bovine Bone Mineral.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Graft
Keywords: maxillary sinus augmentation
bone graft
bovine bone mineral
dental implants
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: the relative amount of mineralised tissue (=newly formed bone plus BO)
timeFrame: 20 monthes
Secondary outcomes:
measure: Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue.
timeFrame: 20 monthes
measure: Clinical parameters:
timeFrame: 32 monthes
measure: complications during surgery related to the material.
timeFrame: 20 monthes
measure: post-operative complications.
timeFrame: 20 monthes
measure: Max torque for implant insertion.
timeFrame: 20 monthes
measure: short-term implant survival (up to one year post loading)
timeFrame: 32 monthes
Other outcomes:
Locations:
city: Jerusalem,
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: department of periodontology, Hadassah Medical Organization
name: Lior Shapira, PhD, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: department of periodontology,Hadassah Medical Organization
name: Tali Chackartchi, DMD
role: STUDY_DIRECTOR
References: