Immediate Versus Early Loading Protocols in Rehabilitation of Fully Edentulous Maxilla: A 5-Year Pilot Randomized Clinical Trial.
Abstract
Objective
To compare 5-year outcomes of immediate versus early loading protocols for complete implant-supported fixed dental prostheses in edentulous maxillae.
Materials And Methods
A prospective randomized controlled trial evaluated 24 patients (144 Bone Level Tapered SLActive implants) assigned to immediate loading (n = 12, 72 implants) or early loading (n = 12, 72 implants). Outcome measures included implant and prosthesis survival rates, marginal bone loss (MBL), buccal plate thickness (BPT), implant stability (ISQ), Oral Health Impact Profile-19 (OHIP-19) and patient satisfaction (Visual Analog Scale).
Results
At the 5-year follow-up, 3 participants (12.5%) discontinued study participation (1 patient from the immediate loading group and 2 patients from the early loading group). Five-year implant and prosthesis survival rates showed no statistically significant differences between groups. Implant survival was 98.6% with immediate loading and 97.2% with early loading (p = 0.610), while prosthesis survival was 91.67% and 100%, respectively (p = 0.317). Buccal marginal bone loss was significantly greater in the immediate loading group (-1.15 mm vs. -0.36 mm, p = 0.010). Mechanical complications occurred more frequently in the immediate loading group (p = 0.015). Four of five periimplantitis occurred in immediately loaded implants (p = 0.310). Peri-implant mucositis affected 55.32% of implants with equal distribution. Patient satisfaction remained high in both groups.
Conclusion
Both immediate and early loading achieved comparable implant and prosthesis survival rates at 5 years. However, immediate loading resulted in significantly greater buccal marginal bone loss. Both protocols provided excellent patient outcomes and can be considered viable options for maxillary rehabilitation with adequate primary stability. TRIAL REGISTRATION This clinical trial was registered after participant recruitment and randomization (NCT07574099).