RESUMO
PURPOSE: The aim of this randomized controlled clinical trial was to evaluate peri-implant marginal bone levels (MBLs) and soft tissue dimension changes 1 year after loading. Patients in the control group received bone-level implants, whereas in the test group, tissue-level implants with a convergent transmucosal neck were used. MATERIAL AND METHODS: MBLs were calculated by measuring the distance from the implant shoulder to the first visible bone-to-implant contact using standardized periapical digital radiographs. Baseline (day of loading) and follow-up digital models obtained with an intraoral scanner were used to quantify the changes in the peri-implant soft tissue dimensions with a best-fit algorithm. RESULTS: The difference between final and baseline MBLs showed a mean bone loss of 0.16 ± 0.01 mm in the test group (n = 15) and 0.45 ± 0.09 mm in the control group (n = 14) (p > 0.05). Soft tissue contour at the level of the gingival margin (GM) increased by 1.96 ± 2.69 mm in the test group and 0.65 ± 0.42 mm in the control group (p = 0.167). Both groups showed a coronal displacement of the gingival margin with no significant differences among them. CONCLUSIONS: The present study demonstrated peri-implant hard and soft tissues stability at both implant designs with no significant differences 12 months after loading. CLINICAL RELEVANCE: There is still insufficient scientific evidence to demonstrate the role and advantages of the convergent transmucosal neck on the behavior of the peri-implant soft and hard tissues stability compared to a straight neck in bone-level implants 12 months after loading.