Effectiveness of polycaprolactone impregnated 3D printed hydroxyapatite in lateral maxillary sinus augmentation: a randomized controlled clinical trial

ObjectivesTo evaluate the clinical efficacy of polycaprolactone impregnated with 3D-printednanohydroxyapatite (3DP HAPCL) in comparison to the commercial xenograft (Straumann®Xenograft) for lateral maxillary sinus augmentation prior to dental implant placement.Material and methodsTwenty patients, including 22 maxillary sinuses, who underwent lateral maxillary sinusaugmentation were allocated and randomized into two groups: Xenograft (control group, 11sinuses) and 3DP HAPCL (test group, 11 sinuses). After six months, biopsy bone cores werecollected from all patients. Clinical, radiographic (vertical bone height and bone volume), micro-CT (percentage of new bone formation and residual bone graft), and histological data (percentageof new bone formation and residual bone graft) were analyzed at baseline, immediately postsurgery,at six months, and one year post-operation.ResultsAll patients had their prostheses fully loaded and were followed up three months afterloading. The survival and success rates were 100% in the control group and 81.81% in the testgroup. The stability of both grafting materials showed no statistically significant difference inheight and volume after one year of lateral maxillary sinus augmentation. However,histomorphometry and micromorphometry analyses revealed a statistically significant lowerpercentage of new bone formation in the test group compared to the control group while the amountof residual bone graft remained unchanged at six months post-operation. Additionally, otherclinical parameters, including sulcus bleeding index, plaque index, probing depth and marginalbone level were within normal limits.ConclusionBased on this study, 3DP HAPCL composite demonstrates potential as an alternative bonegraft material to deproteinized bovine bone mineral.