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Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction when socket preservation is not applied. In addition, extraction of posterior maxillary teeth causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main challenges for dental implant placement. Different bone substitutes have been used to augment bone in pneumatized maxillary sinuses.
Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a viable alternative.
Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with xenografts revealed newly formed bone to be mostly woven bone with some remodeling to lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to be an effective method for maxillary sinus grafting and demonstrate limited resorption over time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully integrate based on recent histomorphometric studies. Vascularization and trabecular bone formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3 salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis). ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3) allowing for the uptake of calcium ions from the physiological solution and releasing phosphate and silicate ions which aid in bone formation. A material with such properties will substitute bone in a more controlled and effective combination that can be obtained in many clinical situations, without the disadvantages found with autograft. ShefaBone has demonstrated successful regenerative properties for bony defects. To our knowledge, there is no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary sinus. This aim of this current study is to compare SCPC to commonly used xenograft material in an augmented maxillary sinus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material. |
|
| Test Group | Experimental | The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shefabone | Biological | Silica-calcium phosphate composite. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements | Bone density will be measured by limited view CBCT radiography pre- and post-operatively. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Quality | Bone quality will be measured using histomorphometric analysis. | 5.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohanad Al-Sabbagh, DDS | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
Beneficial information for further research around the topic and/or information that may aid/benefit subjects or dentists in treatment may be shared.
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24 participants were consented for the study but 2 did not meet eligibility criteria and did not receive an intervention
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material. Bio-Oss: Xenograft Bone substitute. Bone from animals. |
| FG001 | Test Group | The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute. Shefabone: Silica-calcium phosphate composite. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material. Bio-Oss: Xenograft Bone substitute. Bone from animals. |
| BG001 | Test Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements | Bone density will be measured by limited view CBCT radiography pre- and post-operatively. | Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment | Posted | Mean | Standard Deviation | percentage of bone height shrinkage | 5 months |
|
5 months
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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 | Control Group | Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material. Bio-Oss: Xenograft Bone substitute. Bone from animals. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohanad Al-Sabbagh | University of Kentucky | 859-257-3003 | malsa2@email.uky.edu |
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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 | Sep 7, 2023 | Mar 18, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| C077540 | Bio-Oss |
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Randomized controlled clinical trial. Entails 2 groups of subjects which will be randomly assigned. Group 1 will be the control group, and group 2 is test group.
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| Bio-Oss |
| Biological |
Xenograft Bone substitute. Bone from animals. |
|
|
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
Shefabone: Silica-calcium phosphate composite.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Bone Quality | Bone quality will be measured using histomorphometric analysis. | Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment | Posted | Mean | Standard Deviation | percentage of mineralized bone formation | 5.5 months |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Test Group | The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute. Shefabone: Silica-calcium phosphate composite. | 0 | 7 | 0 | 7 | 0 | 7 |
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