Parikh-Das Amisha M, Sharma Naresh Chandra, Du Qiong, Charles Christine Ann
J Clin Dent. 2013;24(3):94-9.
The objective of this randomized, examiner-blind, parallel, controlled clinical study was to compare the antiplaque/antigingivitis efficacy of an essential oil-containing mouthrinse (EO) to a new 0.075% cetylpyridinium chloride mouthrinse (CPC) using a two-week experimental gingivitis model with a 5% hydroalcohol rinse serving as the negative control.
After signing informed consents and completing baseline examinations, 185 subjects were randomized into three groups. Subjects began supervised/recorded rinsing with 20 ml of their assigned rinse for 30 seconds twice daily for two weeks, with no mechanical oral hygiene permitted. Baseline and two-week assessments were conducted as follows: Turesky Modification of the Quigley-Hein Plaque Index (PI), Modified Gingival Index (MGI), and the Gingival Bleeding Index (BI). Analysis of efficacy variables (i.e., mean PI, mean MGI, mean BI, and proportion of bleeding sites derived from the BI) was performed using a one-way analysis of covariance (ANCOVA).
Among the 182 subjects who completed the study, the EO rinse showed statistically significant reductions compared to the negative control within the range previously reported in this model; PI = 36.5% (p < 0.001) and MGI = 17.5% (p < 0.001). A 43.2% reduction in proportion of bleeding sites (p < 0.001) was demonstrated. Mean PI, MGI, and proportion of bleeding sites at two weeks were statistically significantly lower for the EO rinse compared to the CPC rinse (p < 0.001), showing 27.7%, 11.9%, and 30.0% reductions, respectively.
An EO rinse provided superior antigingivitis/antiplaque efficacy compared to a 0.075% CPC rinse in this short-term clinical trial, and demonstrated efficacy within the range shown in previous studies using this model.
本随机、检查者盲法、平行对照临床研究的目的是,采用为期两周的实验性牙龈炎模型,以5%的含醇漱口水作为阴性对照,比较含精油漱口水(EO)与新型0.075%西吡氯铵漱口水(CPC)的抗牙菌斑/抗牙龈炎疗效。
在签署知情同意书并完成基线检查后,185名受试者被随机分为三组。受试者开始使用20毫升分配的漱口水,每天监督/记录两次,每次30秒,持续两周,期间不允许进行机械口腔卫生清洁。基线和两周评估如下:Turesky改良的Quigley-Hein菌斑指数(PI)、改良牙龈指数(MGI)和牙龈出血指数(BI)。使用单向协方差分析(ANCOVA)对疗效变量(即平均PI、平均MGI、平均BI以及BI得出的出血部位比例)进行分析。
在完成研究的182名受试者中,与阴性对照相比,EO漱口水显示出具有统计学意义的降低,在该模型先前报道的范围内;PI = 36.5%(p < 0.001),MGI = 17.5%(p < 0.001)。出血部位比例降低了43.2%(p < 0.001)。与CPC漱口水相比,EO漱口水在两周时的平均PI、MGI和出血部位比例在统计学上显著更低(p < 0.001),分别降低了27.7%、11.9%和30.0%。
在这项短期临床试验中,与0.075%的CPC漱口水相比,EO漱口水具有更优的抗牙龈炎/抗牙菌斑疗效,并且在使用该模型的先前研究中显示的范围内证实了疗效。