The goal of this clinical trial is to histologically understand if collagenic or collagen enriched graft in sinus lift of healthy volunteers needing for implants in the posterior maxillae may work. The main question it aims to answer are:
which material works better histologically and radiologically? Researchers will compare a collagenic graft to collagen enriched graft to see if the osteointegration of the material is the same.
Participants will undergo a sinus lift with one of the two materials and after six month will undergo a bone sample collection to allow the implant insertion.
twelve moths thereafter, a radiograph will be taken to measure the extension of the bone regeneration and implant behavior
Patient requiring vertical elevation of the maxillary sinus floor.
Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus <5 mm.
Males and females between 30-80 years old
Patients with healthy periodontal conditions (treated periodontitis, PI<25%, BoP<25%).
Patients who smoke more than 5 cigarettes/day
Pregnancy (confirmed by verbal inquiry)
Chronic systemic pathologies (e.g. diabetes) and neoplasms of the oro-facial district.
Patients undergoing treatment with antiresorptive agents.
Single group
transcrestal sinus lift
Procedure/SurgeryTranscrestal sinus floor elevation (tSFE) is a surgical technique released through the use of guided surgery and specifically designed drills aimed to release the sinus mucosa. The use of micro elevators is aimed to detach the mucosa from the bone and free the space for the graft material. Graft material is inserted using specific pluggers.
histomorphometric analysis
For standardized analysis, each bone core will be divided into 2.5 mm-long segments. Although efforts will be made to obtain cores of uniform length (7-8 mm), there is the possibility that intact samples will be not always retrievable due to mechanical fragility during trephine extraction or decalcification. For this reason, the segmental analysis approach will be adopted as the methodological standard: poorly mineralized samples, in which only a limited segment could be evaluated, will be thus not weighted equally to longer, structurally intact specimens. Non-regenerated portions will be excluded from analysis when their mechanical integrity is compromised. Percentage of regenerated bone, native bone, graft, connective tissue will be measure
histologic analysis
Hematoxylin and eosin (H\&E) staining will be used for a semi-quantitative assessment of inflammatory infiltrates, based on a previously validated scoring system.Additionally, immunohistochemistry (Osteolcin, Osteopontin, Osteonectin, RUNX2, TRAP, PAS) and Herovici, Sirius Red, RGB Trichrome will be run.
linear radiologic measures
To assess dimensional changes in the grafted area, preoperative, immediately post operative and 6-month postoperative CBCT scans will be analyzed. Variations in the augmented region will be evaluated in terms of bone height and graft volume. For linear measurements, the implant site will be used as a reference, and assessments will be performed along the ideal implant axis, previously determined using 3D planning software. Crestal bone height (CBH) will. be defined as the vertical distance between the alveolar crest and the sinus floor. Sinus width will be measured as the medio-buccal dimension at 10 mm from the crest. A threshold of 12 mm will be used to define the sinus as either wide (\>12 mm) or narrow (≤12 mm). Sinus width will be measured as the medio-buccal dimension at 10 mm from the crest. A threshold of 12 mm will be used to define the sinus as either wide (\>12 mm) or narrow (≤12 mm).
3D radiologic measures
For each implant site, a STL file of the grafted volume will be generated. STL files will be then processedto calculate the total graft volume, expressed in cubic millimeters
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