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| Name | Class |
|---|---|
| American Regent, Inc. | INDUSTRY |
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The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.
The purpose of this investigation is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using three different bone graft materials. Null Hypothesis is that there is no histomorphometric difference in new bone formation in maxillary sinuses augmented using three different materials; anorganic bovine bone graft (Bio-Oss), anorganic equine bone graft (Equimatrix) and mineralized bone allograft (OSSIF-i sem). Patients who require sinus augmentation prior to implant placement will be selected to participate in this study. All patients will be randomly placed into three groups according to bone graft materials that will be used. Group A (Control group,n=10): Maxillary sinus augmentation using anorganic bovine bone graft (Bio-Oss), Group B (Test group,n=10):Maxillary sinus augmentation using anorganic equine bone graft (Equimatrix), and Group C (Test group,n=10):Maxillary sinus augmentation using mineralized bone allograft (OSSIF-i sem). All the patients will be treated with the same surgical technique consisting of sinus floor augmentation via a lateral approach.After a full-thickness flap reflection to expose the lateral wall of the sinus each antrostomy will be outlined with a carbide round bur and sinus membranes will be carefully elevated. If a perforation to the sinus membrane occurs, and if the perforation is < 5 mm in diameter and is able to be repaired, the surgeon will continue the procedure. Any perforation > 5 mm will be excluded from this study. Bone graft materials will be placed into the each sinus compartment for the three groups. After 8 months of healing, biopsy specimen will be collected from the previous antrostomy sites. Histomorphometric measurements of the percentage of vital bone of the area of bone. The percentage of non-bone material (allograft or xenograft) and the percentage of connective tissue will be also analyzed. Then the primary hypothesis will be analyzed statistically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinus augmentation using Bio-oss | Experimental | Sinus augmentation using Bio-oss |
|
| Sinus augmentation using Equimatrix | Experimental | Sinus augmentation using Equimatrix |
|
| Sinus augmentation using OSSIF-i sem | Experimental | Sinus augmentation using OSSIF-i sem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinus augmentation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Vital Bone in a Total Amount of a Bone Specimen | Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis. | 24months |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone. | Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis. | 24months |
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Inclusion Criteria:
Exclusion Criteria:
A medical history that will complicate the outcome of the study such as:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Kan, DDS, MS | Loma Linda University School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University School of Dentistry | Loma Linda | California | 92350 | United States |
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The enrolled patients had either unilateral or bilateral maxillary sinus requiring maxillary sinus graft. For patients with bilateral sinus, each maxillary sinus was randomly assigned different treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sinus Augmentation Using Equimatrix | Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc) |
| FG001 | Sinus Augmentation Using Bio-oss | Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc) |
| FG002 | Sinus Augmentation Using OSSIF-i Sem | Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Either partially or completely edentulous posterior maxilla were included. In event of a bilateral maxillary sinuses, each maxillary sinus was randomly assigned different groups. Therefore, the number of participants overlaps. Two sinuses in Bio-Oss group, 1 sinus in Equimatrix group were removed from the study according to the study protocol.
| ID | Title | Description |
|---|---|---|
| BG000 | Sinus Augmentation Using Bio-oss | Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc) |
| BG001 | Sinus Augmentation Using Equimatrix |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The numbers of analyzed were based on the numbers of maxillary sinuses, therefore, the total number of unique participants is different. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Vital Bone in a Total Amount of a Bone Specimen | Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis. | Posted | Mean | Standard Deviation | percentage of vital bone | 24months | Maxillary sinuses | Maxillary sinuses |
|
Adverse event was monitored up to 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sinus Augmentation Using Bio-oss | Sinus augmentation using Bio-oss Sinus augmentation Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maxillary sinus infection | Infections and infestations | Systematic Assessment | An acute sinus infection was noted in one sinus in the group of sinus augmentation using Bio-Oss. The graft materials were removed. maxillary sinus compartment was cleaned, irrigated and the area was sutured after the sinus graft procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Joseph Kan | Loma Linda University | (909) 558-4980 | jkan@llu.edu |
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| ID | Term |
|---|---|
| D059546 | Sinus Floor Augmentation |
| C000589424 | equimatrix |
| C077540 | Bio-Oss |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016025 | Bone Transplantation |
| D019637 | Orthopedic Procedures |
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| Equimatrix | Drug | Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc) |
|
| OSSIF-i sem | Drug | OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2 |
|
| Bio-oss | Drug | Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc) |
|
Sinus augmentation using Equimatrix
Sinus augmentation
Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc)
| BG002 | Sinus Augmentation Using OSSIF-i Sem | Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc |
| BG003 | Total | Total of all reporting groups |
| Maxillary sinus |
|
| Mean |
| Full Range |
| years |
| Maxillary sinus |
|
| Age, Customized | Number | participants | Participants |
|
| Sex/Gender, Customized | Number | participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| OG002 | Sinus Augmentation Using OSSIF-i Sem | Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc |
|
|
| Secondary | The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone. | Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis. | Posted | Mean | Standard Deviation | percentage of residual bone materials | 24months | Maxillary Sinuses | Maxillary Sinuses |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Sinus Augmentation Using Equimatrix | Sinus augmentation using Equimatrix Sinus augmentation Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc) | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Sinus Augmentation Using OSSIF-i Sem | Sinus augmentation using OSSIF-i sem Sinus augmentation OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc | 0 | 10 | 0 | 10 | 0 | 10 |
|
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| D003813 | Dentistry |