Jared Heather, Zhong Yan, Rowe Monika, Ebisutani Kadushi, Tanaka Toshiyuki, Takase Naoko
The University of North Carolina at Chapel Hill Chapel Hill, NC, USA.
J Clin Dent. 2005;16(2):47-52.
This single-blind, five parallel-arm, four-week randomized clinical trial was designed to compare the efficacy of a 0.05% cetylpyridinium chloride gel-releasing interdental brush (IDB) with standard interproximal cleaning devices for plaque and gingivitis reduction, and decreased frequency in interproximal gingival bleeding.
After consenting, participants meeting inclusion criteria brushed their teeth, received a baseline examination and a professional cleaning, and were then block-randomized into five groups, with the plaque level serving as the blocking variable. All five groups performed standard tooth brushing as a background regimen. Three of the groups were respectively assigned to one of three interdental brush regimens, the fourth group was assigned to a standard flossing regimen (positive control), and the fifth group was assigned to a standard tooth brushing only regimen (control). Clinical outcome data were collected at two and four weeks.
Of a total of 162 starting participants, 152 completed the study. There were no baseline differences among the five groups with respect to age, interproximal plaque score, interproximal gingivitis score, or percent of interproximal bleeding on probing. After two and four weeks, the 3 IDB groups exhibited 30-40 percent lower plaque levels than the control (p < 0.05). With respect to interproximal gingival scores, the active agent IDB group exhibited a statistically significant effect after two weeks, and all three IDB groups demonstrated significantly better outcomes after four weeks (p < 0.05). At two and four weeks, the three IDB groups demonstrated a greater reduction in interproximal bleeding points upon probing compared to the two control groups (p < 0.05). The group using the 0.05% cetylpyridinium gel-releasing IDB system did not demonstrate superior clinical results when compared to the two other IDB groups.
When compared to control and positive control interdental cleaning procedures, daily use of IDBs was effective in reducing interproximal plaque and gingivitis scores, as well as interproximal bleeding on probing. The benefits were evident at two weeks, but were more consistent after four weeks. The 0.05% cetylpyridinium gel-releasing IDB system did not appear to confer a consistently independent incremental benefit.
本单盲、五平行组、为期四周的随机临床试验旨在比较含0.05%西吡氯铵凝胶的牙间隙刷（IDB）与标准邻面清洁器械在减少牙菌斑和牙龈炎以及降低邻面牙龈出血频率方面的疗效。
在获得同意后，符合纳入标准的参与者刷牙，接受基线检查和专业洁牙，然后按牙菌斑水平作为分层变量进行区组随机分组，分为五组。所有五组均以标准刷牙作为基础治疗方案。其中三组分别分配到三种牙间隙刷治疗方案之一，第四组分配到标准牙线治疗方案（阳性对照），第五组分配到仅标准刷牙治疗方案（对照）。在两周和四周时收集临床结局数据。
总共162名初始参与者中，152名完成了研究。五组在年龄、邻面菌斑评分、邻面牙龈炎评分或探诊时邻面出血百分比方面，基线无差异。两周和四周后，三个牙间隙刷组的牙菌斑水平比对照组低30%-40%（p<0.05）。关于邻面牙龈评分，活性剂牙间隙刷组在两周后显示出统计学显著效果，所有三个牙间隙刷组在四周后均显示出明显更好的结果（p<0.05）。在两周和四周时，与两个对照组相比，三个牙间隙刷组在探诊时邻面出血点的减少更为明显（p<0.05）。与其他两个牙间隙刷组相比，使用含0.05%西吡氯铵凝胶的牙间隙刷系统的组未显示出更优的临床结果。
与对照和阳性对照的牙间隙清洁程序相比，每日使用牙间隙刷在减少邻面牙菌斑和牙龈炎评分以及探诊时邻面出血方面有效。益处两周时明显，但四周后更稳定。含0.05%西吡氯铵凝胶的牙间隙刷系统似乎并未带来持续独立的额外益处。
