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一项评估假牙黏附剂预防部分义齿佩戴者食物嵌塞的随机交叉试验。

A randomized crossover trial assessing denture adhesive for prevention of food infiltration among partial denture wearers.

机构信息

The Procter & Gamble Company, Mason, Ohio, USA,

The Procter & Gamble Company, Mason, Ohio, USA.

出版信息

Am J Dent. 2024 Aug;37(4):216-220.

PMID:39186604
Abstract

PURPOSE

This two-treatment, four-period, double-blind, randomized controlled crossover trial assessed the ability of two denture adhesives, both applied with a thin nozzle in a continuous application pattern, to prevent food infiltration beneath partial dentures.

METHODS

Participants with mandibular partial dentures and a history of food particle infiltration were enrolled. All participants used both an optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (PVM/MA) denture adhesive and a calcium/sodium partial salt of PVM/MA test denture adhesive, twice each, throughout four study periods, according to a randomly assigned sequence. At each visit, participants underwent two assessments: once with no denture adhesive (baseline) and once with denture adhesive, 1 hour after adhesive application. For each assessment, participants ate one-half of the top of a poppy seed muffin, and a dental professional counted the seeds retained on the denture and mucosa, which was the primary variable. The change-from-baseline comparison was made for each treatment separately using a paired t-test or Wilcoxon Signed Rank test depending on the normality of the data. A between-treatment comparison for the change from baseline was performed using a crossover ANCOVA with treatment and period as fixed effects and participant as a random effect. The baseline poppy seed count was used as a covariate.

RESULTS

30 participants were enrolled; 29 completed the trial. Both denture adhesives achieved statistically significantly fewer retained seeds versus baseline (P< 0.001). The calcium/zinc adhesive reduced the seed count from baseline by 85.9% (6.18 vs 0.86), and the calcium/ sodium adhesive reduced seed count by 76.6% (6.04 vs 1.43). Comparing the two denture adhesives, the reduction in seed count from baseline was statistically significantly greater for the calcium/zinc adhesive versus the calcium/sodium formulation (P= 0.008).

CLINICAL SIGNIFICANCE

These results support the recommendation of denture adhesive use for the prevention of food infiltration beneath partial dentures, with optimized calcium/zinc denture adhesive showing the greatest prevention benefit.

摘要

目的

本项两治疗、四周期、双盲、随机对照交叉试验评估了两种义齿黏附剂的作用,两种黏附剂均采用细管、连续涂抹的方式应用,以预防局部义齿下食物渗透。

方法

纳入下颌有局部义齿且有食物颗粒渗透史的参与者。所有参与者均使用两种义齿黏附剂,一种是优化的聚维酮甲基醚/马来酸钙/锌部分盐(PVM/MA),另一种是 PVM/MA 钙/钠部分盐,在四个研究周期内每种黏附剂各使用两次,按照随机分配顺序使用。每次就诊时,参与者接受两次评估:一次不使用义齿黏附剂(基线),一次使用义齿黏附剂后 1 小时。每次评估时,参与者食用一半罂粟籽松饼顶部,由一名牙科专业人员计算义齿和黏膜上残留的种子,这是主要变量。使用配对 t 检验或 Wilcoxon 符号秩检验(取决于数据的正态性)分别对每种治疗的基线变化进行比较。使用交叉协方差分析(ANCOVA),以治疗和周期为固定效应,参与者为随机效应,对治疗间从基线的变化进行比较。使用基线罂粟籽计数作为协变量。

结果

纳入 30 名参与者,29 名完成了试验。两种义齿黏附剂与基线相比,残留的种子数量均显著减少(P<0.001)。钙/锌黏附剂使种子计数从基线减少了 85.9%(6.18 比 0.86),钙/钠黏附剂使种子计数减少了 76.6%(6.04 比 1.43)。比较两种义齿黏附剂,钙/锌黏附剂与钙/钠配方相比,从基线减少的种子数量统计学上显著更高(P=0.008)。

临床意义

这些结果支持推荐使用义齿黏附剂预防局部义齿下食物渗透,优化的钙/锌义齿黏附剂显示出最大的预防效果。

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