Combined effect of new complete dentures and simple dietary advice on nutritional status in edentulous patients: study protocol for a randomized controlled trial.

BACKGROUND
Individuals who are edentulous have a lower intake of fruit, vegetables, fiber, and protein compared with their dentate counterparts because tooth loss is accompanied by a decrease in ability to chew. Whether or not a combination of prosthetic rehabilitation and simple dietary advice produces improvement in dietary intake among edentulous persons is unclear. We aim to investigate the effect of a simultaneous combination of simple dietary advice delivered by dentists and provision of new complete dentures on dietary intake in edentulous individuals who request new dentures.

METHODS/DESIGN
Through a double-blinded, parallel, randomized controlled trial in which 70 edentate persons who request new complete dentures will be enrolled, eligible study participants will be randomly allocated to either a dietary intervention group receiving dietary advice or to a control group receiving only advice on the care and maintenance of dentures. Outcome measures include daily intake of nutrients and food items, assessed using a brief self-administered diet history questionnaire; antioxidant capacity, determined using blood and urine samples; nutritional status, assessed with the Mini-Nutritional Assessment-Short Form; oral health-related quality of life, assessed with the Japanese version of the Oral Health Impact Profile-EDENT and the Geriatric Oral Health Assessment Index; subjective chewing ability; masticatory performance, assessed using a color-changeable chewing gum and a gummy jelly; patient self-assessment of dentures; mild cognitive impairment, assessed with the Japanese version of the Montreal Cognitive Assessment; and functional capacity, assessed with the Japan Science and Technology Agency Index of Competence. Outcome measures, except for antioxidant capacity, are to be implemented at three time points: at baseline and at 3 and 6 months following intervention. Antioxidant capacity data are to be collected twice: at baseline and at 3 months following intervention. Differences between the groups at 3 and 6 months and within-group changes are to be compared using the paired t test.

DISCUSSION
Simple dietary advice that can be implemented by a dentist would be more practical in clinical practice than tailored dietary counseling. The results of this study will provide beneficial information on dietary intake changes for both edentulous individuals requesting new complete dentures and dentists.

TRIAL REGISTRATION
University Hospital Medical Information Network Center Unique Trial Number: UMIN000017879 . Registered on 12 June 2015.