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

Study Overview
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Brief Summary
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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
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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, large1-2 mm, and small0.25-1 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.

Official Title
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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

Conditions
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Sinus Graft

Intervention / Treatment
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* Device: bovine bone mineral particles (Bio-Oss®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>small particles | Device: bovine bone mineral particles (Bio-Oss®)<br>* bovine bone mineral particles used for sinus augmentation prior to dental implant placement<br>* Other names: bovine bone mineral particles (Bio-Oss®) large particles;|
| Active Comparator: 2<br>large particles | Device: bovine bone mineral particles (Bio-Oss®)<br>* bovine bone mineral particles used for sinus augmentation prior to dental implant placement<br>* Other names: bovine bone mineral particles (Bio-Oss®) large particles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relative amount of mineralised tissue (=newly formed bone plus BO) |  | 20 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative amount of newly formed bone, graft residues, bone marrow, residual bone and connective tissue. |  | 20 monthes | 
| Clinical parameters: |  | 32 monthes | 
| complications during surgery related to the material. |  | 20 monthes | 
| post-operative complications. |  | 20 monthes | 
| Max torque for implant insertion. |  | 20 monthes | 
| short-term implant survival (up to one year post loading) |  | 32 monthes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maxillary sinus augmentation, bone graft, bovine bone mineral, dental implants