Statement of problem

The addition of palatal rugae to complete dentures has been suggested to improve the satisfaction of patients with different oral functions. However, clinical studies to support these claims are lacking.

Purpose

The purpose of this randomized, single-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures with palatal rugae compared with a polished palate.

Material and methods

Edentulous patients aged 45 to 80 years, with no relevant medical conditions, seeking complete dentures at a university hospital between May and July 2019 were recruited. Each participant received new complete dentures. After a 1-week adaptation period, the participants were randomly allocated to 2 sequences through a computer-generated sequence. In the first sequence, palatal rugae were added to the complete dentures, and after 2 months, the palatal rugae were removed and the dentures used for another 2 months. In the second sequence, the opposite sequence was followed: polished palate first and palatal rugae second. After each period, a blinded dentist asked participants to rate their general satisfaction on a 100-mm visual analog scale (primary outcome) and to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). The paired sample t test and the Wilcoxon test were used (α=.05).

Results

Fifty participants were randomized, of whom 6 dropped out. No significant differences were found between ratings for the 2 palatal contours in terms of general satisfaction 2.32 (95% confidence interval: -3.65 to 8.29, P=.438), eating 1.70 (95% confidence interval: -4.05 to 7.46, P=.554), taste perception 0.57 (95% confidence interval -5.04 to 6.17, P=.839), phonetics 1.48 (95% confidence interval -4.46 to 7.41, P=.618), or speaking 3.68 (95% confidence interval: -1.92 to 9.28, P=.192). However, satisfaction with ease of cleaning dentures with palatal rugae was significantly less 12.16 (95% confidence interval: 6.81 to 17.50, P<.001). The differences in the OHIP-EDENT total scores were not significantly different -1.75 (95% confidence interval: -3.7 to 0.23, P=.082). Differences in each item ratings were also found to be not significantly different (P>.05), except for the frequency of mealtime interruption (P=.041), which was reported to increase when rugae had been provided.

Conclusions

Complete dentures with palatal rugae were not perceived to improve patient satisfaction or oral health–related quality of life. However, they were perceived to be more difficult to clean and to increase frequency of interruptions during eating.

中文翻译：

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在全口义齿中添加腭皱对患者满意度和口腔健康相关生活质量的影响：一项随机交叉临床试验

问题陈述

有人建议在全口义齿中加入腭皱，以提高不同口腔功能患者的满意度。然而，缺乏支持这些说法的临床研究。

目的

这项随机、单盲、2 周期交叉试验的目的是评估无牙患者的满意度及其口腔健康影响情况，与抛光腭相比，提供带有腭皱的全口义齿。

材料与方法

招募年龄在 45 至 80 岁，无相关医疗条件，于 2019 年 5 月至 7 月期间在大学医院寻求全口义齿的缺牙患者。每个参与者都收到了新的全口假牙。经过 1 周的适应期后，参与者通过计算机生成的序列被随机分配到 2 个序列。第一个序列，在全口义齿上加腭皱，2个月后，去除腭皱，再用2个月。在第二个序列中，遵循相反的序列：首先是抛光的上颚，然后是上颚皱褶。在每个时期之后，一位不知情的牙医要求参与者在 100 毫米视觉模拟量表（主要结果）上评价他们的总体满意度，并评价他们对饮食、味觉、说话、语音、和易于清洁。参与者还被要求填写 20 项无牙患者口腔健康影响概况 (OHIP-EDENT)。配对样本使用 t检验和 Wilcoxon 检验 (α=.05)。

结果

50 名参与者被随机分配，其中 6 人退出。在总体满意度 2.32（95% 置信区间：-3.65 至 8.29，P =.438）、进食 1.70（95% 置信区间：-4.05 至 7.46，P = .554），味觉 0.57（95% 置信区间 -5.04 至 6.17，P =.839），语音 1.48（95% 置信区间 -4.46 至 7.41，P =.618），或说话 3.68（95% 置信区间： -1.92 到 9.28，P =.192）。然而，对带有腭皱的义齿清洁难度的满意度显着低于 12.16（95% 置信区间：6.81 至 17.50，P<.001）。OHIP-EDENT 总分的差异无显着差异 -1.75（95% 置信区间：-3.7 至 0.23，P =.082）。除了进餐时间中断的频率 ( P = .041) 外，每个项目评分的差异也没有显着差异 ( P > .05)，据报道，当提供皱褶时，这种频率会增加。

结论

人们认为带有腭皱褶的全口义齿不能提高患者满意度或口腔健康相关的生活质量。然而，人们认为它们更难清洁，并且会增加进食中断的频率。