Jose Anto, Atassi Mounir, Shneyer Lucy, Cronin Matthew
GlaxoSmithKline Consumer Healthcare Oral Health Research and Development, Weybridge, Surrey, UK.
Shneyer Statistics LLC, Denville, NJ, USA.
J Clin Dent. 2017 Jun;28(2):32-38.
This study examined ratings of two subjective aspects (moisturization and dry mouth relief) that may be changed following the use of dry mouth relief products (an oral gel, an oral rinse, or a mouth spray), in comparison to water over a period of four hours following a single supervised use on two separate occasions.
This was a single-center, two site, randomized, examiner blind, four treatment arm, stratified (by dry mouth screening score at baseline), parallel group study in healthy subjects with a self-reported feeling of dry mouth. Prior to product use, subjects rated their current subjective perception of moisturization and dry mouth on an 11-point scale. Subjects then rated the two questions immediately after product use and 30, 60, 90, 120, and 240 minutes later. At the 240-minute time point, subjects also rated global efficacy questions regarding "overall" and "long-lasting" moisturization and dry mouth relief, and overall product opinion. Subjects then used their assigned products at home for three days and the procedures were repeated on Day 4.
In total, 300 subjects were randomized to treatment. Compared with water, all test products showed statistically significantly greater improvements over baseline on both Day 1 and Day 4 at most time points, on the area under the curve from baseline for the moisturization and dryness questions, and after 240 minutes for the global efficacy and overall opinion assessments (all p < 0.05). There was a statistically significant difference between the pre-dosing assessments on Day 1 versus Day 4 (p < 0.001) for both efficacy questions. Products were generally well-tolerated.
Three different types of dry mouth relief products were shown to provide significant relief of dry mouth and increased feelings of moisturization compared to water using subjective questionnaires.
本研究考察了在两次单独的单次监督使用后四个小时内，与水相比，使用口干缓解产品（口腔凝胶、口腔漱口水或口腔喷雾）后可能发生变化的两个主观方面（保湿和口干缓解）的评分。
这是一项单中心、双地点、随机、检查者盲法、四治疗组、分层（按基线时的口干筛查评分）、平行组研究，研究对象为自我报告有口干感觉的健康受试者。在使用产品前，受试者用11分制对其当前的保湿和口干主观感受进行评分。然后，受试者在使用产品后立即以及30、60、90、120和240分钟后对这两个问题进行评分。在240分钟时间点，受试者还对关于“整体”和“持久”保湿及口干缓解的总体疗效问题以及对产品的总体评价进行评分。然后，受试者在家中使用指定产品三天，并在第4天重复上述程序。
总共300名受试者被随机分配接受治疗。与水相比，在第1天和第4天的大多数时间点，所有测试产品在保湿和干燥问题的基线曲线下面积以及240分钟后的总体疗效和总体评价评估方面，与基线相比均显示出统计学上显著更大的改善（所有p<0.05）。对于这两个疗效问题，第1天和第4天给药前评估之间存在统计学上的显著差异（p<0.001）。产品总体耐受性良好。
与水相比，三种不同类型的口干缓解产品通过主观问卷调查显示能显著缓解口干并增强保湿感。
