Effect of an Oral Frailty Measures Program on Community-Dwelling Elderly People: A Cluster-Randomized Controlled Trial

Introduction: Oral frailty describes a trivial decline in the oral function and is considered to be related to frailty. Thus, effective management of oral frailty could prevent or ameliorate physical frailty and the need for care. However, there is a lack of consensus regarding specific interventions for oral frailty. In this cluster-randomized controlled trial, we investigated the effects of a newly developed oral frailty measures program mentored by dentists and dental hygienists for elderly people in a clinical setting. Methods: Of 3,296 participants included in a field survey, 219 who regularly visited dental clinics and met at least 3 of the following 6 criteria for oral frailty were considered eligible: <20 natural teeth, decreased chewing ability, decreased articulatory oral-motor skills, decreased tongue pressure, and substantial subjective difficulties in eating and swallowing. After applying the inclusion and exclusion criteria, we studied 51 patients in the intervention group (14 men and 37 women; mean age, 78.6 years) and 32 patients in the control group (7 men and 25 women; mean age, 78.0 years). We implemented a 12-week oral frailty measures program only for the intervention group. The program included preparatory oral exercises, mouth-opening training, tongue pressure training, prosodic training, and masticatory training. Primary outcome measures were the chewing ability score, articulatory oral motor skill for /ta/, tongue pressure, subjective difficulty in eating tough foods, and subjective difficulty in swallowing. We compared baseline characteristics using the Mann-Whitney U and chi(2) tests for continuous and categorical variables, respectively. A repeated-measures two-way ANOVA was used to determine the efficacy of independent intervention variables, following the Wilcoxon signed-rank test. The groups (intervention/control) and time (baseline/week 12) were the independent variables. Oral frailty measures were the dependent variables. Results: Baseline characteristics and assessment results were similar between groups. We observed significant improvements in the intervention group in terms of articulatory oral motor skill for /ta/ and tongue pressure (p < 0.001). No improvements were observed in the control group. Discussion/Conclusion: Our results suggest that our oral frailty measures program effectively alleviates oral frailty. Future studies are needed to clarify the impact on preventing physical frailty and improving the nutritional status.