OBJECTIVE: This one-year randomized clinical trial compared the effects of mandibular implant-overdentures (IODs) on two two-piece regular-neck tissue-level implants (Group A) or on four mini-implants (Group B) with different loading protocols in edentulous patients concerning dental Patient-Reported Outcomes (dPROs). MATERIAL AND METHODS: Seventy-two participants were randomly assigned to Group A (n = 35) for treatment with two standard implants (3.3 mm diameter, conventional loading) with a stud-type abutment, or to Group B (n = 37) for treatment with four mini-implants (2.4 mm diameter, immediate loading) with a mini-stud-type abutment. Primary outcomes were measured using the General Oral Health Assessment Index (GOHAI), the 14-item Oral Health Impact Profile (OHIP-G14), and the Denture Satisfaction Index (DSI), at visit #1-baseline (pre-treatment), visit #2-implant placement (immediate loading, Group B), visit #3-8-10-week follow-up (conventional loading, Group A; control visit, Group B), and visit #4-1-year post-placement. Data analysis included descriptive statistics, non-parametric comparison tests, effect-size measures, and multiple regression. RESULTS: Sixty-two participants completed the 1-year follow-up (Group A = 32; Group B = 30). Significantly improved dPROs were observed for both treatments after 1 year, compared with baseline (p < 0.01), with similar effects in the two Groups. In the mini-implant group, higher improvement in satisfaction was observed after implant placement and immediate loading, compared to Group A (p < 0.001). CONCLUSION: Significant improvements in satisfaction and Oral Health Related Quality of Life were observed after 1 year, and benefits were observed earlier for mini-implants using immediate loading. Overall, findings support the use of four immediately loaded mini-implants in the mandible as a suitable treatment alternative for edentulous patients. REGISTRATION: ClinicalTrials.Gov ID: NCT03837158. https://clinicaltrials.gov/study/NCT03837158.
Schimmel et al. (Mon,) studied this question.