Borden Loretta C, Chaves Eros S, Bowman James P, Fath Barbara M, Hollar Garry L
Consumer Products Testing Division, Hill Top Research, Inc., Cincinnati, Ohio, USA.
Compend Contin Educ Dent. 2002 Jun;23(6):531-6, 538, 540 passim; quiz 548.
The purpose of the study was to compare the efficacy of four mouthrinses in clinical outcomes of changes in oral malodor measurements in a 4-week, randomized, double-blind, longitudinal clinical trial in adults. The four rinses were coded as Products 1, 2, 3, and 4 so that neither the examiners nor subjects had the knowledge of treatment. Of the four mouthrinses, two were commercially available mouthrinses with essential oils (EO) or chlorine dioxide plus zinc (CD/Zn) as active ingredients (Products 1 and 4), one mouthrinse was a formulation containing cetylpyridinium chloride (Product 2), and one was a placebo (Product 3). A total of 99 subjects who met the study criteria were assigned randomly to one of the four groups. At three separate visits (0, 2, and 4 weeks), subjects received an examination of the oral soft tissues and were assessed for baseline oral malodor by two organoleptic judges and a laboratory instrument that measures oral malodor. Subjects were instructed to use the assigned rinse, and the measurements were performed again after 2 and 4 hours. Throughout the 4-week study period, each subject was asked to use the assigned rinse twice daily per the manufacturer's recommended directions. The results showed that the four mouthrinses reduced oral malodor within 4 hours after a single usage, with Product 2 being the most effective and the placebo being the least effective. Daily use of EO, CD/Zn, and placebo rinses for up to 4 weeks did not reduce oral malodor from week 0 baseline values, and the effects on oral malodor were comparable among these three mouthrinses. Product 2 was the only mouthrinse that reduced oral malodor from baseline values after 2 and 4 weeks of daily use.
本研究的目的是在一项针对成年人的为期4周的随机、双盲、纵向临床试验中,比较四种漱口水在改善口腔异味测量临床结果方面的疗效。这四种漱口水分别编码为产品1、2、3和4,以使检查人员和受试者都不知道所接受的治疗。在这四种漱口中,两种是市售漱口水,其活性成分分别为精油(EO)或二氧化氯加锌(CD/Zn)(产品1和4),一种漱口水是含有氯化十六烷基吡啶的制剂(产品2),另一种是安慰剂(产品3)。共有99名符合研究标准的受试者被随机分配到四组中的一组。在三次单独的访视(0周、2周和4周)时,对受试者的口腔软组织进行检查,并由两名感官评判员和一台测量口腔异味的实验室仪器对基线口腔异味进行评估。受试者被指示使用分配的漱口水,并在2小时和4小时后再次进行测量。在整个4周的研究期间,要求每个受试者按照制造商推荐的说明每天使用分配的漱口水两次。结果表明,四种漱口水在单次使用后4小时内均能减轻口腔异味,其中产品2最有效,安慰剂最无效。每天使用EO、CD/Zn和安慰剂漱口水长达4周,并未使口腔异味从第0周的基线值降低,并且这三种漱口水对口腔异味的影响相当。产品2是唯一一种在每天使用2周和4周后能使口腔异味从基线值降低的漱口水。