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The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material , and the percentage of connective tissue.
Bovine xenograft has been established as a gold standard in maxillary sinus floor augmentation. This study was initiated to compare two different types of bovine xenografts following maxillary sinus floor augmentation. The comparison will performed using histomorphometric analysis of bone cores removed from the grafted sites. The patients that meet the guidelines for maxillary sinus floor augmentation via lateral window approach are randomly assigned into control and test groups. The surgery is performed by the same surgeon under the same protocols. The subjects in Group A - test group receive InterOss bone graft and subjects in Group B- Control Group receive BioOss bone graft. After eight months of healing at the sites, the patients are subjected to CBCT evaluation in preparation for implant placement. At the time of implant placement the two bone cores are collected from each grafted site using trephine burs. One bone core is collected from the crestal bone that will be site of implant placement and the second bone core is collected from the lateral window area not to interfere with the implant site. These bone cores are stored intact inside the trephine burs, fixed, stored and transported to the lab for histomorphometric analysis. The following parameters are measured and reported after the histomorphometric analysis.
percentage of vital bone percentage of non-vital bone ( graft material) percentage of non-bone material percentage of connective tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InterOss | Experimental | Maxillary sinus augmentation using ABBM Inteross ( Xenograft) |
|
| Bio-oss | Active Comparator | Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterOss | Device | Anorganic bovine bone mineral - Xenograft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of New Vital Bone. | Vital bone as seen in histology from the collected bone cores. | 8 months post operative after the initial sinus augmentation surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentage of Bone Marrow and Fibrous Tissue | Cumulative percentage of Bone marrow and fibrous tissue as seen in histology. | Eight months post-op sinus augmentation |
| Space | Space seen the histology specimen not filled with either bone or fibrous tissue in the bone core specimens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Lozada | Loma Linda University | 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 unit of enrollment here is one maxillary sinus that qualifies for grafting via lateral window approach. 9 patients were recruited who had 15 qualified maxillary sinus' in this study.
| ID | Title | Description |
|---|---|---|
| FG000 | InterOss | Maxillary sinus augmentation using ABBM Inteross ( Xenograft) InterOss: Anorganic bovine bone mineral - Xenograft |
| FG001 | Bio-oss | Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft) Bio-oss: Anorganic bovine bone mineral ( Xenograft) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
These participants were selected for grafting of the maxillary sinus floor based on the minimum availability of the bone present in that area for implant placement.
| ID | Title | Description |
|---|---|---|
| BG000 | InterOss | Maxillary sinus augmentation using ABBM Inteross ( Xenograft) InterOss: Anorganic bovine bone mineral - Xenograft |
| BG001 | Bio-oss | Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft) Bio-oss: Anorganic bovine bone mineral ( Xenograft) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of New Vital Bone. | Vital bone as seen in histology from the collected bone cores. | Subjects requiring sinus augmentation for implant placement | Posted | Mean | Standard Deviation | percentage of new vital bone | 8 months post operative after the initial sinus augmentation surgery. | Sinus | Sinus |
|
Adverse events data collected through nine months after sinus augmentation
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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 | InterOss | Maxillary sinus augmentation using ABBM Inteross ( Xenograft) InterOss: Anorganic bovine bone mineral - Xenograft |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarat Ummethala | Loma Linda University Health | 909 558 4983 | saratdoc@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2021 | Aug 15, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2021 | Aug 15, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| Bio-oss |
| Device |
Anorganic bovine bone mineral ( Xenograft) |
|
| 8 months |
| BG002 | Total | Total of all reporting groups |
| Maxillary sinus |
|
| years |
| Participants |
|
|
| Sex: Female, Male | The unit measured is the number of Maxillary sinus. The participants are number of people in the study. Some of the patients had one maxillary sinus that qualified for the study and some of the patients had both maxillary sinuses that qualified for the study. | Count of Units | Maxillary sinus | Maxillary sinus |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
|
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| Secondary | Cumulative Percentage of Bone Marrow and Fibrous Tissue | Cumulative percentage of Bone marrow and fibrous tissue as seen in histology. | Subjects requiring sinus augmentation for implant placement | Posted | Mean | Standard Deviation | Cumulative percentage | Eight months post-op sinus augmentation |
|
|
|
| Secondary | Space | Space seen the histology specimen not filled with either bone or fibrous tissue in the bone core specimens. | Subjects requiring sinus augmentation for implant placement | Posted | Mean | Standard Deviation | percentage of space not filled with bone | 8 months |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Bio-oss | Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft) Bio-oss: Anorganic bovine bone mineral ( Xenograft) | 0 | 5 | 0 | 5 | 0 | 5 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |