Missing Teeth
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInterOss
Anorganic bovine bone mineral - Xenograft
DEVICEBio-oss
Anorganic bovine bone mineral ( Xenograft)
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 103 Years
Healthy volunteers
Yes
Inclusion criteria
1. Over 18 years old who are able to read and sign an informed consent form. 2. Patient who has good oral hygiene (Full-mouth plaque score \<25%). 3. Subject would be available for study monitoring and follow-up visits. 4. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous. 5. Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting
Exclusion criteria
1. Alcohol, drug dependency. 2. Signs or symptoms of chronic maxillary sinus disease. 3. Current smoker. 4. History of head and neck radiation treatment. 5. Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease. 6. Physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations. 7. Also, subjects who are nursing or pregnant will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of New Vital Bone. | 8 months post operative after the initial sinus augmentation surgery. | Vital bone as seen in histology from the collected bone cores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Percentage of Bone Marrow and Fibrous Tissue | Eight months post-op sinus augmentation | Cumulative percentage of Bone marrow and fibrous tissue as seen in histology. |
| Space | 8 months | Space seen the histology specimen not filled with either bone or fibrous tissue in the bone core specimens. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| InterOss Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
InterOss: Anorganic bovine bone mineral - Xenograft | 4 |
| InterOss Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
InterOss: Anorganic bovine bone mineral - Xenograft | 6 |
| Bio-oss Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Bio-oss: Anorganic bovine bone mineral ( Xenograft) | 5 |
| Bio-oss Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Bio-oss: Anorganic bovine bone mineral ( Xenograft) | 9 |
| Total | 24 |
Baseline characteristics
| Characteristic | Bio-oss | Total | InterOss |
|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 2.3 | 59.6 years STANDARD_DEVIATION 4.3 | 63.0 years STANDARD_DEVIATION 4.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Maxillary sinus | 5 Maxillary sinus | 3 Maxillary sinus |
| Sex: Female, Male Male | 7 Maxillary sinus | 10 Maxillary sinus | 3 Maxillary sinus |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
Percentage of New Vital Bone.
Vital bone as seen in histology from the collected bone cores.
Time frame: 8 months post operative after the initial sinus augmentation surgery.
Population: Subjects requiring sinus augmentation for implant placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| InterOss | Percentage of New Vital Bone. | Lateral core | 16.33 percentage of new vital bone | Standard Deviation 8.43 |
| InterOss | Percentage of New Vital Bone. | Crestal core | 30.5 percentage of new vital bone | Standard Deviation 5.86 |
| Bio-oss | Percentage of New Vital Bone. | Lateral core | 26.11 percentage of new vital bone | Standard Deviation 11.63 |
| Bio-oss | Percentage of New Vital Bone. | Crestal core | 39.67 percentage of new vital bone | Standard Deviation 3.52 |
Secondary
Cumulative Percentage of Bone Marrow and Fibrous Tissue
Cumulative percentage of Bone marrow and fibrous tissue as seen in histology.
Time frame: Eight months post-op sinus augmentation
Population: Subjects requiring sinus augmentation for implant placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| InterOss | Cumulative Percentage of Bone Marrow and Fibrous Tissue | Lateral core | 56.33 Cumulative percentage | Standard Deviation 5.57 |
| InterOss | Cumulative Percentage of Bone Marrow and Fibrous Tissue | Crestal core | 50.17 Cumulative percentage | Standard Deviation 5.53 |
| Bio-oss | Cumulative Percentage of Bone Marrow and Fibrous Tissue | Lateral core | 51.67 Cumulative percentage | Standard Deviation 6.48 |
| Bio-oss | Cumulative Percentage of Bone Marrow and Fibrous Tissue | Crestal core | 46.33 Cumulative percentage | Standard Deviation 8.91 |
Secondary
Space
Space seen the histology specimen not filled with either bone or fibrous tissue in the bone core specimens.
Time frame: 8 months
Population: Subjects requiring sinus augmentation for implant placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| InterOss | Space | Lateral core | 27.33 percentage of space not filled with bone | Standard Deviation 13.54 |
| InterOss | Space | Crestal core | 19.5 percentage of space not filled with bone | Standard Deviation 4.59 |
| Bio-oss | Space | Lateral core | 22.11 percentage of space not filled with bone | Standard Deviation 10.15 |
| Bio-oss | Space | Crestal core | 14.00 percentage of space not filled with bone | Standard Deviation 12.51 |