A randomized clinical trial of phycogenic materials for sinus grafting with hydroxyapatite versus biphasic calcium phosphate: 2 years clinical outcomes.

Objectives: To assess in a prospective randomized trial two phycogenic bone substitutes—biphasic calcium phosphate (BCP) versus almost pure hydroxyapatite (HA)—for their volume stability and clinical implications after sinus floor elevation (SFE). Materials and Methods: Twenty patients requiring lateral‐window SFE 6 months prior to implant surgery were randomized to a BCP or HA group. As primary outcome, the grafts were analyzed for volume stability, using four cone‐beam computed tomography scans obtained immediately/6/12/24 months after SFE. Secondary outcomes were implant survivval, success, periotest values, oral‐health‐related quality of life (OHIP‐G14), and pain (VAS). Results: Kolmogorov–Smirnov goodness‐of‐fit test revealed normal distribution of samples (p =.200). At 6/12/24 months, the augmented volumes decreased to 96/92/90% (HA) or 99/96/96% (BCP). Volume changes were significantly a factor of time (p <.001; generalized linear model with repeated measures) and reached significantly lower values in HA group (p =.018). Significant intergroup difference in volume losses was notable at 24 months (p =.021; t‐test for independent samples). Periotest values decreased from −3/−4.1 (HA/BCP) after implant placement to −6.3/−4.5 (HA/BCP) after 6 months. OHIP scores diverged at 2 months (HA: 9.5; BCP: 5.2) and largely resolved by 24 months (HA: 1.3; BCP: 1.9). VAS scores were comparable, 2.2 at 1 week after SFE being their highest mean level. Conclusions: After 2 years, both groups experienced no biological or technical complications, demonstrating a consistent healing trajectory without notable symptoms. Although no significant differences were observed in implant stability and survival, BCP demonstrated higher volume stability than HA. [ABSTRACT FROM AUTHOR]