Endo-sinus bone gain following osteotome-mediated sinus floor elevation with Bio-Oss Collagen compared with no grafting material: a one-year single-blind randomized controlled trial.

The objective of this study was to assess endo-sinus bone gain (ESBG) following osteotome-mediated sinus floor elevation with Bio-Oss Collagen (test) compared with no grafting material (control) using two- and three-dimensional radiographic methods, as part of a randomized controlled trial (ClinicalTrials.gov, NCT04618900). Forty healthy patients who met the necessary eligibility criteria were allocated by block randomization to either the test group (20 patients) or control group (20 patients). Cone beam computed tomography scans were obtained at enrolment (T0), immediately after surgery (T1), at delivery of the prosthetic rehabilitation (T2), and 1 year after functional implant loading (T3). Mean differences were expressed with the 95% confidence interval; significance was set at P < 0.05. ESBG was significantly increased with Bio-Oss Collagen compared with no grafting material at T1, T2, and T3 (P < 0.001). A gradual decrease in ESBG was observed over time with both treatment modalities (P < 0.001), which diminished the difference between the test and control groups at T2 and T3. ESBG was observed to be positively correlated with implant protrusion length and negatively correlated with the residual bone height. In osteotome-mediated sinus floor elevation, the application of Bio-Oss Collagen underneath the elevated Schneiderian membrane improved ESBG significantly when compared with no grafting material. However, the increased ESBG seems not to have positively improved the treatment outcomes in terms of the implant stability quotient or the survival of the implants or suprastructures.