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义齿黏附剂的主观评价:一项多中心随机对照试验

Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial.

作者信息

Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T

机构信息

The Japan Denture Care Society.

Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.

出版信息

JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.

DOI:10.1177/2380084419837607
PMID:30975019
Abstract

INTRODUCTION

Many reports show that denture adhesives improve the retention and stability of dentures. However, few randomized controlled trials have examined the effects of denture adhesives.

OBJECTIVE

This 10-center randomized controlled trial with parallel groups involving 200 edentulous patients wearing complete dentures aimed to evaluate the effects of short-term use of cream and powder denture adhesives.

METHODS

Patients were allocated into 2 cream- and powder-type adhesive groups and 1 control group. Intervention groups were treated with the 2 adhesives (1 each), and the control group received saline solution. Adhesive or control was applied to the denture-mucosal surface for 4 d, and data at baseline and after day 4 of intervention (i.e., 8 meals) were obtained. Patient satisfaction was evaluated with a 100-mm visual analog scale. Oral health-related quality of life was measured with the Japanese version of the Oral Health Impact Profile for Edentulous Patients. Perceived chewing ability was evaluated by a questionnaire regarding ease of chewing and swallowing food. Between-group comparisons were performed with Kruskal-Wallis tests with the Mann-Whitney test adjusted by Bonferroni correction. Within-group comparisons of pre- and postintervention measurements were performed with the Wilcoxon signed-rank test. Intention-to-treat analysis was also performed.

RESULTS

Between-group comparisons showed no significant differences for general satisfaction or Oral Health Impact Profile for Edentulous Patients. However, significant differences in satisfaction with various denture functions with cream- and powder-type adhesives were seen in pre- and postintervention comparisons ( < 0.05). Significant differences were also observed for perceived chewing ability of hard foods ( < 0.05).

CONCLUSION

These results suggest that although denture adhesives do not invariably improve denture function, they do affect subjective evaluations and possibly chewing of hard foods. Therefore, the effects of denture adhesive use are insufficient to resolve any fundamental dissatisfaction with dentures ( ClinicalTrials.gov NCT01712802 ).

KNOWLEDGE TRANSFER STATEMENT

The results of this study suggest that denture adhesives should be applied under certain conditions; however, an appropriate diagnosis is important before application. These practice-based data provide information to establish evidence-based guidelines for applying denture adhesives.

摘要

引言

许多报告表明,义齿粘合剂可提高义齿的固位和稳定性。然而,很少有随机对照试验研究义齿粘合剂的效果。

目的

这项有10个中心参与的平行组随机对照试验,涉及200名佩戴全口义齿的无牙患者,旨在评估短期使用乳膏型和粉末型义齿粘合剂的效果。

方法

将患者分为2个乳膏型和粉末型粘合剂组以及1个对照组。干预组分别使用这2种粘合剂(各1种)进行治疗,对照组接受生理盐水。将粘合剂或对照物涂抹在义齿 - 粘膜表面4天,并获取基线数据和干预第4天(即8餐)后的数据。使用100毫米视觉模拟量表评估患者满意度。使用日本版无牙患者口腔健康影响概况量表测量与口腔健康相关的生活质量。通过关于咀嚼和吞咽食物难易程度的问卷评估感知咀嚼能力。组间比较采用Kruskal - Wallis检验,并通过Bonferroni校正进行Mann - Whitney检验。干预前后测量的组内比较采用Wilcoxon符号秩检验。还进行了意向性分析。

结果

组间比较显示,总体满意度或无牙患者口腔健康影响概况量表方面无显著差异。然而,在干预前后比较中,乳膏型和粉末型粘合剂在对各种义齿功能的满意度方面存在显著差异(P < 0.05)。在硬质食物的感知咀嚼能力方面也观察到显著差异(P < 0.05)。

结论

这些结果表明,尽管义齿粘合剂并非总能改善义齿功能,但它们确实会影响主观评价,并且可能影响硬质食物的咀嚼。因此,使用义齿粘合剂的效果不足以解决对义齿的任何根本不满(ClinicalTrials.gov NCT01712802)。

知识转移声明

本研究结果表明,义齿粘合剂应在特定条件下使用;然而,在应用前进行适当诊断很重要。这些基于实践的数据为制定义齿粘合剂应用的循证指南提供了信息。

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