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To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenograft - Autogenous 1:4 | Experimental | Sinus grafted with a ratio of Xenograft - Autogenous 1:4 |
|
| Xenograft alone | Active Comparator | Sinus grafted with Xenograft only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinus Lift augmentation | Procedure | Randomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological analysis | Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate | 4 months from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric bone analysis 4 months post sinus augmentation | Sinus volume calculation via CBCT analysis | 4 months from surgery |
| Radiographic bone height gain at 4 months | Residual alveolar crest Final alveolar crest height at 4 months Initial height of graft immediately post graft placement Vertical bone material resorption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Mordini, DDS, MS | Tufts Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35881815 | Background | Al-Moraissi E, Alhajj WA, Al-Qadhi G, Christidis N. Bone Graft Osseous Changes After Maxillary Sinus Floor Augmentation: A Systematic Review. J Oral Implantol. 2022 Oct 1;48(5):464-471. doi: 10.1563/aaid-joi-D-21-00310. | |
| 31230768 | Background | Al-Moraissi EA, Alkhutari AS, Abotaleb B, Altairi NH, Del Fabbro M. Do osteoconductive bone substitutes result in similar bone regeneration for maxillary sinus augmentation when compared to osteogenic and osteoinductive bone grafts? A systematic review and frequentist network meta-analysis. Int J Oral Maxillofac Surg. 2020 Jan;49(1):107-120. doi: 10.1016/j.ijom.2019.05.004. Epub 2019 Jun 21. |
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Clinical examiners, study surgeons, and subjects will not be blinded. Analysis of histomorphometric, histologic, and volumetric data will be completed by an external lab and will not be aware of what group the subjects were in.
| Cone-beam computed tomography systems (CBCT) | Device | An research only use of CBCT at visit 2 to review healing status. |
|
| 4 months post sinus augmentation |
| 16161735 | Background | Barone A, Crespi R, Aldini NN, Fini M, Giardino R, Covani U. Maxillary sinus augmentation: histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):519-25. |