Abstract
DESIGN: A single-center (university-setting), prospective, longitudinal, split-mouth, single-blind, randomized controlled clinical trial investigated peri-implant parameters of bone-level implants restored with either screw-retained prostheses connected directly to the implants or with intermediate abutments over a 3-year period. The study adhered to the ethical principles of the Helsinki Declaration and the CONSORT guidelines. Ethical approval was granted, and the trial was registered at Clinicaltrials.gov . CASE SELECTION: Participants included were over 18 years of age, had a plaque index below 25%, and were missing at least two adjacent teeth, allowing for rehabilitation with screw-retained fixed partial prostheses over two implants and 2-4 prosthetic units. Exclusion criteria included long-term use of medications affecting bone metabolism, smoking more than 10 cigarettes per day, history of local radiotherapy, untreated periodontitis, and the need for rehabilitation in the anterior sextant of the maxilla. The primary clinical outcome was marginal bone loss (MBL), while secondary outcomes included probing pocket depth (PPD), plaque index (PI), bleeding on probing (BOP), and patient-reported outcomes (PROs). STUDY TIMELINE: The study schedule included a screening (visit 1), implant surgery (visit 2), stage-two 8 weeks post-surgery (visit 3), impressions taken 4 weeks post stage-two (visit 4), baseline standardized radiograph (visit 5), followed by 6-month (visit 6), 12-month (visit 7), and 36-month (visit 8) follow-up visits. DATA ANALYSIS: Descriptive statistics and quantitative measures included means, standard deviations (SDs), minimum and maximum values, and 95% confidence intervals (CIs). Clinical parameters (six sites per implant) measured were MBL, PPD, PI, and BOP. Paired t tests were utilized for intragroup comparisons across different time points and intergroup comparisons at each time point. PROs at 36 months were compared using Student's t test. The alpha significance level was set at 0.05. RESULTS: The study included 36 patients (72 implants), with two not completing the follow-up due to death and relocation. No implants showed signs of inflammation or mobility. Mean interproximal bone level (IBL) at baseline was 0.13 mm ± 0.15 mm for the control group and 0.10 ± 0.13 mm for the test group. At the 36-month follow-up, mean IBL was 0.13 ± 0.18 mm for the control group and 0.20 ± 0.24 mm for the test group, with no significant differences (F(1, 32) = 1.06; p > 0.05). Clinical parameters (PPD, BOP, PI) at 36 months showed no significant differences between groups. Minor complications occurred in 6.7% of the control group and 5.3% of the test group. PROs indicated no significant differences in general satisfaction, esthetics, comfort, phonetics, and masticatory function between the groups. CONCLUSIONS: After a 36-month follow-up, bone-level implants restored with CAD/CAM prostheses directly connected to the implants displayed similar clinical outcomes, PROs, and marginal bone level changes as those restored with intermediate standardized abutments.