Maxillary sinus augmentation with three different biomaterials: Histological, histomorphometric, clinical, and patient-reported outcomes from a randomized controlled trial

Background: Lateral maxillary sinus augmentation (MSA) is a predictable bone regeneration technique in case of atrophy of the posterior-upper maxilla. Aimed at obtaining quantity and quality of bone suitable for receiving osseointegrated implants, its success is largely due to the skill of the surgeon, but also to the characteristics of the biomaterial used. Methods: Twenty-four patients needing MSA were included in the study. The patients were randomly allocated to three different groups: anorganic bovine bone mineral as control, tricalcium phosphate with or without hyaluronic acid (HA) as test groups. Nine months after MSA, bone biopsies were harvested for the histomorphometric analysis. Secondary outcomes were mean bone gain, intraoperative and postoperative complications, implant insertion torque, implant failure, and patient-reported outcome measures. Results: Although the percentage of new bone was not statistically different between the three groups (P =.191), the percentages of residual biomaterial was significantly higher (P <.000) and nonmineralized tissue significantly lower (P <.000) in the control than in the test groups. Test groups did not differ significantly from each other for all histomorphometric parameters. The implant insertion torque was significantly higher in the control group (P <.0005). The rest of the secondary outcomes were not significantly different between the groups. Conclusion: MSA is a safe and predictable procedure in terms of histological, clinical, and PROAMs, regardless of the biomaterial used. The addition of HA did not influence the outcomes.