Hase J C, Söder P O, Söder B, Kulstad S, Kelty E
Clinical Research Department, Biosurface AB, Malmö, Sweden.
Eur J Oral Sci. 1995 Jun;103(3):172-8. doi: 10.1111/j.1600-0722.1995.tb00020.x.
A double-blind, randomized, 2-wk experimental gingivitis clinical trial with cross-over design in 14 dental students was conducted in order to study the efficacy and safety of delmopinol hydrochloride solution (2 mg/ml), used with no other oral hygiene procedures, in comparison with placebo. Plaque formation was measured by the Quigley & Hein Plaque Index and gingivitis was assessed by bleeding on probing according to Mühlemann & Son. Rinsing with delmopinol resulted in lower plaque scores compared to placebo. The development of gingivitis was weak during the 2-wk test periods, and thus no conclusive results were obtained. As in previous studies, the most frequent adverse event when rinsing with delmopinol was a transient anaesthetic sensation in the oral mucosa. The results showed that rinsing with delmopinol hydrochloride solution (2 mg/ml) for 60 s twice daily with no other oral hygiene procedures led to less plaque formation than rinsing with placebo. This study also showed good tolerance and acceptability of mouthrinsing with delmopinol.
对14名牙科学生进行了一项为期2周的双盲、随机、交叉设计的实验性牙龈炎临床试验,以研究在不进行其他口腔卫生措施的情况下,与安慰剂相比,2mg/ml盐酸地莫匹醇溶液的疗效和安全性。采用Quigley&Hein菌斑指数测量菌斑形成情况,根据Mühlemann&Son的方法通过探诊出血评估牙龈炎。与安慰剂相比,用盐酸地莫匹醇漱口可降低菌斑评分。在为期2周的测试期间,牙龈炎的发展较为轻微,因此未得出确凿结果。与之前的研究一样,用盐酸地莫匹醇漱口时最常见的不良事件是口腔黏膜出现短暂的麻醉感。结果表明,在不进行其他口腔卫生措施的情况下,每天两次用2mg/ml盐酸地莫匹醇溶液漱口60秒,与用安慰剂漱口相比,导致的菌斑形成更少。这项研究还表明,用盐酸地莫匹醇漱口具有良好的耐受性和可接受性。