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The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen®), compared with control material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyophilized Equine Bone Allograft | Experimental | Sinus Lift with Lyophilized Equine Bone Allograft |
|
| deproteinized bovine bone allograft | Active Comparator | Sinus lift with deproteinized bovine bone allograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Histomorphometric Evaluation of New Bone Formation. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GIUSEPPE MARZO, DMD | University of L'Aquila | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lyophilized Equine Bone Allograft | Sinus Lift with Lyophilized Equine Bone Allograft sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) |
| FG001 | Deproteinized Bovine Bone Allograft |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) |
| Device |
|
Sinus lift with deproteinized bovine bone allograft
Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)
| COMPLETED |
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| NOT COMPLETED |
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16 patients with a residual crest height of 4 mm or less.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lyophilized Equine Bone Allograft | Sinus Lift with Lyophilized Equine Bone Allograft sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) |
| BG001 | Deproteinized Bovine Bone Allograft | Sinus lift with deproteinized bovine bone allograft Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Caucasian patients with a residual crest height ≤4 mm who need sinus lift augmentation for dental implant placement. Enrolled patients were randomly assigned either to DEBM or AAB groups by a software (STATA/12.1, StataCorp LLC, College Station, TX, USA). | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Histomorphometric Evaluation of New Bone Formation. | Caucasion patients aged ≥ 25 years with at least one atrophic posterior maxilla (distally from first bicuspid teeth) with a residual crest height ≤4 mm who need sinus lift augmentation for dental implant placement were eligible for the study. | Posted | Mean | Standard Deviation | percentage of millimeters | 6 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 | Lyophilized Equine Bone Allograft | Sinus Lift with Lyophilized Equine Bone Allograft sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) | 0 | 8 | 0 | 8 | ||
| EG001 | Deproteinized Bovine Bone Allograft | Sinus lift with deproteinized bovine bone allograft Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrico Marchetti DDS, PhD | Department MESVA - University of L'Aquila | +39862433304 | enrico.marchetti@univaq.it |
| >=65 years |
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| Male |
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| residual graft material |
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