Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
Conditions
Keywords
Posterior maxillary atrophy; Dental implants; Sinus lift; Bone grafting; Platelet-rich fibrin; Alveolar ridge augmentation; Bone regeneration; Bone substitutes
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESinus lift augmentation with bone substitute (Bio-Oss)
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.
PROCEDUREOpen 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
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.
Sponsors
Straumanngroup
Geistlich Pharma AG
University of Santiago de Compostela
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients \>18 years * Presence of oral health (periodontally healthy or periodontitis treated), with a BoP \<20% and PI \<20%. * Systemically healthy, with no disease that might contraindicate oral surgery. * Non-smokers or smokers of \<10 cig/day. * Need to place implants in postero-superior sector with a residual bone height of \< 5mm (no need for vertical regeneration). * More than 3 months since tooth extraction in the treatment area. * Absence of sinus pathology.
Exclusion criteria
* Patients who, due to systemic conditions, blood extraction is not possible. * Medication that may interfere with bone metabolism (e.g. corticosteroids, bisphosphonates). * History of radiotherapy. * Pregnant and/or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of new bone formed | 4 and 6 months after treatment | Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of remaining material (%) | 4 and 6 months after treatment | Measured by histology analysis at 4 and 6 months; |
| Volumetric changes of regenerated bone | baseline, 4 and 12 months after treatment | Measured in millimeters according to CBCT at 4 and 12 months after maxillary sinus lift in apico-coronal and bucco-lingual orientation |
| Implant stability | 4 and 6 months after treatment | Mesured ISQ (\>65N) at the time of implant placement and in the second surgical phase before connecting the abutment to the implant). |
| Implant success | 12 months after treatment | According to the criteria described by Misch,2008 |
Countries
Spain
Outcome results
None listed