Combined effect of new complete dentures and simple dietary advice on nutritional status in edentulous patients: study protocol for a randomized controlled trial
Combined effect of new complete dentures and simple dietary advice on nutritional status in edentulous patients: study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-016-1664-y
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发表时间：
2016-11-09
期刊：
影响因子：
2.5
通讯作者：
Minakuchi, Shunsuke
中科院分区：
文献类型：
--
作者：
Komagamine, Yuriko;Kanazawa, Manabu;Minakuchi, Shunsuke
背景：与有齿牙的人相比，无牙牙的人的水果、蔬菜、纤维和蛋白质的摄入量较低，因为牙齿脱落伴随着咀嚼能力的下降。假肢康复和简单饮食建议的结合是否能改善无牙颌患者的饮食摄入量尚不清楚。我们的目的是研究同时结合牙医提供的简单饮食建议和提供新的全口假牙对要求新假牙的无牙颌患者的饮食摄入量的影响。方法/设计：通过一项双盲、平行、随机对照试验，其中将招募 70 名要求新全口假牙的无牙颌患者，合格的研究参与者将被随机分配到接受饮食干预的饮食干预组中。 饮食建议或仅接受假牙护理和维护建议的对照组。结果指标包括每日营养素和食物的摄入量，使用简短的自我管理饮食史调查问卷进行评估；抗氧化能力，通过血液和尿液样本测定；营养状况，通过简易营养评估简表进行评估；口腔健康相关的生活质量，通过日本版口腔健康影响概况-EDENT 和老年人口腔健康评估指数进行评估；主观咀嚼能力；咀嚼性能，使用变色口香糖和软糖果冻进行评估；患者对假牙的自我评估；轻度认知障碍，使用日本版蒙特利尔认知评估进行评估；和功能能力，通过日本科学技术振兴机构能力指数进行评估。除抗氧化能力外，结果测量将在三个时间点实施：基线时以及干预后 3 个月和 6 个月。抗氧化能力数据将收集两次：基线时和干预后 3 个月时。使用配对 t 检验比较 3 个月和 6 个月时各组之间的差异以及组内变化。讨论：可由牙医实施的简单饮食建议在临床实践中比定制饮食咨询更实用。这项研究的结果将为需要新的全口假牙的无牙颌患者和牙医提供有关饮食摄入变化的有益信息。
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.