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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005374-26 | EudraCT Number |
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| Name | Class |
|---|---|
| Straumanngroup | UNKNOWN |
| Geistlich Pharma AG | INDUSTRY |
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Objective: The main objective of this study is to evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) reduces healing time, through histomorphometric analysis using bone biopsies after maxillary sinus elevation versus the use of deproteinized bovine mineralized bone (DBBM) alone.
Materials and methods: 24 patients with posterior maxillary atrophy (residual bone height <5mm without need for vertical regeneration) and need for sinus lift surgery to allow implant placement were treated ,12 DBBM (control group) 12 L-PRF block (Test group). At 4 months after sinus lift, a biopsy was taken and implants were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. Patients received prosthetic restorations after 9 months and were followed up at 12 months. Volumetric changes were analyzed at 4 and 12 months.
The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design. Patients requiring an open sinus lift procedure before implant placement.
For the procedure it was use two types of filler, L-PRF block (test group) and DBBM alone (control group).
All patients were randomized and assigned to each of the study groups through a computer-generated randomization.
The primary outcome was percentage of new bone formed after treatment by histological and histomorphometric measurement of biopsies (%NeoformedBone=(Regenerated bone/total area)x100) at 4 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Open sinus lift surgery using a bone substitute Bio-Oss®(Geistlich AG, Wolhusen, Switzerland) alone. |
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| Test Group | Experimental | Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinus lift augmentation with bone substitute (Bio-Oss) | Procedure | A maxillary sinus lift augmentation was performed with a lateral window approach that was filled with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®).At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of new bone formed | Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery | 4 and 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of remaining material (%) | Measured by histology analysis at 4 and 6 months; | 4 and 6 months after treatment |
| Volumetric changes of regenerated bone | Measured in millimeters according to CBCT at 4 and 12 months after maxillary sinus lift in apico-coronal and bucco-lingual orientation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of periodontology, Faculty of Dentistry, University of Santiago de Compostela | Santiago de Compostela | 15782 | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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The study compared two groups: one receiving DBBM alone (control) and the other receiving a combination of DBBM and an L-PRF block (test group).
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| Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block | Procedure | A maxillary sinus lift augmentation was performed with a lateral window approach that was filled using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®) (L-PRF block). L-PRF block will be performed as described by Cortellini et al. 2018. L-PRF membranes are cut into small pieces and mixed with Bio-Oss® at a ratio of 2 membranes / 0.5 g biomaterial. Pieces of the block will be removed and compacted in the sinus cavity until it is filled. At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. |
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| baseline, 4 and 12 months after treatment |
| Implant stability | Mesured ISQ (>65N) at the time of implant placement and in the second surgical phase before connecting the abutment to the implant). | 4 and 6 months after treatment |
| Implant success | According to the criteria described by Misch,2008 | 12 months after treatment |
| Related Info | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D018786 | Bone Substitutes |
| C077540 | Bio-Oss |
| ID | Term |
|---|---|
| D001672 | Biocompatible Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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