BackgroundDifferent biomaterials were suggested for sinus floor augmentation (SFA). Recently, new materials were launched showing true bone formation without remnants.PurposeThe aim of this prospective study was to evaluate an hydroxyapatite‐based, sugar cross‐linked collagen sponge (OSSIX™ Bone) in transcrestal SFA (t‐SFA).Materials and methodsTwenty‐four patients with edentulous posterior maxilla and residual bone height (RBH) >4 mm underwent t‐SFA with OSSIX™ Bone as grafting material and simultaneous implant placement. The implant Stability Quotient (ISQ) was measured by resonance frequency analysis (RFA) directly after implant insertion and at 6 months. Differences in bone height (BH) and volume were determined in CBCT and x‐rays at baseline versus 1 year of follow‐up. Graft volume was evaluated by tridimensional reconstructions. Linear regression analysis was used to evaluate the effect of bucco‐palatal sinus dimension, RBH, and length of the implant protruding (PIL) into the sinus, on the graft height (GH) changes up to 1 year, and on the graft volume at 1 year. Autocorrelation between time lag and augmented bone volume was evaluated through time series analysis correlograms. Health‐related quality‐of‐life outcomes were captured.ResultsTwenty‐two patients completed the study. The mean RBH measured at baseline was 5.81 ± 2.2 mm. The mean graft volume was 1085.8 ± 733.4 mm3. The mean GH, measured in the immediate post‐operative period, at 6 and 12 months respectively, was 7.24 mm ±1.94; 6.57 mm ± 2.30; 5.46 mm ± 2.04. The mean ISQ measured after the implant placement was 62.19 ± 8.09, and 6 months later was 76.91 ± 4.50. There was a significant correlation between buccolingual dimension and graft volume at 1 year. Neither buccolingual volume nor RBH had a significant effect on GH change, while the PIL showed a significant positive correlation (P = 0.02 and P = 0.03 at 6 and 12 months, respectively). The correlograms indicated no significant correlation, meaning that there is no tendency for graft volume to increase or decrease over time, therefore suggesting graft stability, at least up to one year of follow‐up. 86% of patients had no chewing interference.ConclusionWithin the limitations of the study, OSSIX™ Bone could be considered a valid material for SFA due to its manageability and its positive results in promoting new bone formation with long‐term stability. T‐SFA is confirmed as a less invasive and less painful method.
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