Design
This study was an extension of a randomized crossover clinical trial approved by the institutional ethics committee (approval number: D2014–148) and adhered to the CONSORT guidelines. The original study juxtaposed patient contentment with single-implant overdentures (1-IODs) against conventional complete dentures (CCDs), with patient satisfaction being the primary focus. In this follow-up study, the cognitive function of edentulous patients receiving 1-IODs was assessed, specifically monitoring for the emergence of mild cognitive impairment (MCI) throughout a three-year period.
Patient outcomes were systematically recorded at predetermined intervals: initially, two months post-1-IOD placement, after one year (with groups alternated between denture types at eight-month marks), then after two and three years. A prosthodontist with a decade of expertise performed all denture-related procedures. This follow-up emphasized the cognitive outcomes using the Montreal Cognitive Assessment (MoCA-J), considering it alongside previously documented results on masticatory function, bone resorption, survival rates, and patient-reported outcomes.
Case selection
Between 2015 and 2016, a follow-up study enrolled edentulous patients over 50 years of age who were proficient in Japanese, had sufficient mandibular bone for implants, and were free of systemic health issues and habits that could impact oral health. The participants were randomly divided into two groups after receiving a central mandibular implant. Group 1 initially used 1-IODs, and Group 2 used unloaded CCDs. After two months and subsequent periods, they swapped denture types. Eventually, all patients chose 1-IODs for continued use. Implant success was monitored over three years.
The design featured block randomization and accounted for a sample size of 22, determined to be sufficient for evaluating the primary outcome of patient satisfaction. All patients underwent careful allocation and received customized dental interventions, with detailed radiographic planning and surgical precision guiding the implantation process.
Data analysis
Multivariable linear mixed models were used to assess within-group changes in both overall and specific cognitive function scores across five timepoints. Age, assessment interval, and upper jaw denture status were incorporated as consistent variables, while individual participants were considered variable elements in the analysis. SPSS software version 22.0 was utilized to conduct the statistical tests, and a p value threshold of 0.05 was predetermined to establish statistical significance.
Results
Twenty-two patients with edentulous mandibles received 1-IODs. Memory and executive functions saw significant score increases at multiple timepoints over the three-year period, with statistical significance. Though one participant dropped out and another passed away, and two did not complete the 3-year follow-up, the remaining 18 participants provided comprehensive data. Age and type of maxillary denture were significant factors, influencing MoCA-J scores with older participants and those with fixed dentures showing lower scores in certain domains. Overall, the findings illustrated the positive correlation between 1-IODs and cognitive function in older adults.
Conclusions
Older adults with no natural teeth left in their mandible showed improved cognitive function after one and three years of using 1-IODs, as reflected by their total and specific cognitive domain scores. The study suggests that such implant therapy may offer protective benefits against cognitive decline, demonstrating clinical relevance for patient care, regardless of the maxillary arch (antagonist) condition.