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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
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Twenty patients scheduled for lateral-window sinus floor Elevation (SFE) are randomized into two groups: use of SYMBIOS® Biphasic Bone Graft Material (Group 1) or of Algipore® Bone Substitution Material (Group 2).
Biopsies are taken 3 months after SFE and during implant surgery after 6 months. One ground section per biopsy (n=40) is stained, scanned, and histomorphometrically analyzed for new bone, old bone, soft tissue, graft, bone infiltration of graft, bone-to-graft contact, and penetration depth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYMBIOS® | Experimental | Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material |
|
| Algipore® | Active Comparator | Sinus augmentation with Algipore® Bone Substitution Material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Symbios Bone Graft Material | Device | Patients will receive Symbios Bone Graft Material according to randomization Group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability | measured with Periotest® | 12 months after sinus augmentation |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate of the implants | Rate of loss of implants | 24 months after sinus augmentation |
| Probing on depth | The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walther Wegscheider, Prof. DDr. | Head of Department | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18705811 | Background | Cordaro L, Bosshardt DD, Palattella P, Rao W, Serino G, Chiapasco M. Maxillary sinus grafting with Bio-Oss or Straumann Bone Ceramic: histomorphometric results from a randomized controlled multicenter clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):796-803. doi: 10.1111/j.1600-0501.2008.01565.x. | |
| 19885448 | Background |
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Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.
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| Algipore Bone Substitution Material | Device | Patients will receive Algipore Bone Substitution Material according to randomization Group. |
|
| 24 months after sinus augmentation |
| Bleeding on probing | 24 months |
| Crestal bone level after implant | measured by means of single tooth x-rays | 12 months after implant placement |
| Complications | Frequency of complications | 6 months after sinus augmentation |
| Newly formed bone area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation |
| Newly formed bone area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation |
| Old bone area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation |
| Old bone area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation |
| Tissue area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation |
| Tissue area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation |
| Bone substitute area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation |
| Bone substitute area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation |
| New bone infiltration area in bone substitute in mm² | measured through histomorphological analysis | 3 months after sinus augmentation |
| New bone infiltration area in bone substitute in mm² | measured through histomorphological analysis | 6 months after sinus augmentation |
| new bone to bone substitute contact in mm | measured through histomorphological analysis | 6 months after sinus augmentation |
| Penetration depth in mm | measured through histomorphological analysis | 3 months after sinus augmentation |
| Penetration depth in mm | measured through histomorphological analysis | 6 months after sinus augmentation |
| Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59. |
| 15015951 | Background | Schopper C, Moser D, Sabbas A, Lagogiannis G, Spassova E, Konig F, Donath K, Ewers R. The fluorohydroxyapatite (FHA) FRIOS Algipore is a suitable biomaterial for the reconstruction of severely atrophic human maxillae. Clin Oral Implants Res. 2003 Dec;14(6):743-9. doi: 10.1046/j..2003.00959.x. |
| 16297691 | Background | Ewers R. Maxilla sinus grafting with marine algae derived bone forming material: a clinical report of long-term results. J Oral Maxillofac Surg. 2005 Dec;63(12):1712-23. doi: 10.1016/j.joms.2005.08.020. |
| 21947545 | Background | Scarano A, Degidi M, Perrotti V, Piattelli A, Iezzi G. Sinus augmentation with phycogene hydroxyapatite: histological and histomorphometrical results after 6 months in humans. A case series. Oral Maxillofac Surg. 2012 Mar;16(1):41-5. doi: 10.1007/s10006-011-0296-3. Epub 2011 Sep 24. |
| 23714235 | Background | Kuhl S, Payer M, Kirmeier R, Wildburger A, Acham S, Jakse N. The influence of particulated autogenous bone on the early volume stability of maxillary sinus grafts with biphasic calcium phosphate: a randomized clinical trial. Clin Implant Dent Relat Res. 2015 Feb;17(1):173-8. doi: 10.1111/cid.12086. Epub 2013 May 28. |
| 30624789 | Background | Raghoebar GM, Onclin P, Boven GC, Vissink A, Meijer HJA. Long-term effectiveness of maxillary sinus floor augmentation: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:307-318. doi: 10.1111/jcpe.13055. |