Objective: This parallel three-group randomised clinical trial compared the 1-year changes in dental patient-reported outcomes and chewing function associated with three treatment strategies for the edentulous mandible: single-implant (G-I; n = 11) or two-implant overdentures (G-II; n = 13), and fixed 4-implant complete denture (G-III; n = 13).
Methods: Complete denture (CD) treatment was provided to all participants and after an adaptation period, they were randomly assigned to one of the three study groups. Implants (Neodent TI Cortical, Brazil) were inserted using single-stage surgery and conventional loading. The mandibular dentures were incorporated into implants using specific retention systems and procedures according to the treatment group: O'ring/ball attachments for G-I and GII, and mini-conical abutments for G-III. Patients were assessed at baseline (CD stage) and up to 1-year after implant-retained prosthodontic treatment. Treatment outcomes included oral health-related quality of life (OHIP-Edent), satisfaction with the dentures and chewing function using a mixing ability test. Data analyses included pairwise comparison tests, estimates of effect sizes and regression analysis using Generalized Estimating Equations.
Results: Results showed improvement in patient-reported outcomes (lower OHIP-Edent scores and higher satisfaction) and chewing function, compared to baseline. No significant between-group differences were found, although effect sizes were lower for G-III.
Conclusions: All treatments improved the assessed outcomes after transition from the baseline condition. Findings suggest that simplified implant treatments for edentulous patients result in favourable outcomes and may be considered as suitable alternatives to more complex interventions.
Keywords: clinical trial; dental implant; elderly population; oral health-related quality of life; overdenture; patient satisfaction.
© 2020 John Wiley & Sons Ltd.