Objective: To report the 1-year implant survival/success and peri-implant outcomes of mandibular overdentures retained by four titanium-zirconium mini implants (Straumann® Mini Implant System), and to assess how surgery and loading protocols influence these outcomes.

Materials and methods: A 2 × 2 factorial randomized clinical trial (RCT) tested the combined effects of two loading protocols (immediate or delayed) and two surgical approaches (flapless or flapped) on the success/survival of the mini implants, and peri-implant parameters (plaque, bleeding, sulcus depth, gingival position, and marginal bone loss). Outcomes were assessed up to 1-year after loading, and generalized estimating equations (GEEs) were used to analyze longitudinal and within-patient clustered data.

Results: Two hundred and ninety-six implants were placed in 74 patients. The implant survival/success rates after 1 year were 100%, and no major biological complications were observed. After 1-year, descriptive data suggest no noticeable changes in plaque scores, whilst a reduction in bleeding scores at the 6-month and 1-year follow-ups compared to baseline. Good longitudinal stability was observed for the probing depth and gingival margin height measures. Overall mean marginal bone loss was 0.68 (±0.68) mm after 3 months and 0.89 (±0.75) mm after 1-year. The flapless protocol showed better results on soft tissue stability and health but a slightly higher risk for marginal bone loss.

Conclusion: The results of this RCT suggest that mandibular overdentures retained by this novel mini implant system represent a safe and predictable treatment option as confirmed by implant survival/success and peri-implant outcomes, even when flapless surgery and immediate loading protocols are adopted.