Kohut B, Coelho J, Sharma N C, Galustians J, Proskin H M
Warner-Lambert Co., Morris Plains, NJ, USA.
J Clin Dent. 1999;10(4):119-23.
This pilot clinical study was conducted to evaluate the utility of a short-term brushing model for assessing the inhibition of supragingival plaque and gingivitis by an essential oil-containing dentifrice formulation. Forty-two qualifying subjects entered and completed this double-blind, parallel group, controlled study. At baseline, subjects received an oral soft and hard tissue examination and were also scored for plaque, gingivitis and bleeding, both visually and invasively. Subjects received a supragingival prophylaxis and were randomly assigned to an experimental essential oil-containing dentifrice or its vehicle control. Subjects brushed unsupervised for one minute, twice daily for three weeks, after which all clinical examinations were repeated. All examinations were performed by a qualified and calibrated examiner. Analyses of covariance were used to compare inter-group means for each of the three outcome variables. Compared to its vehicle control, the experimental dentifrice produced statistically significant (p < 0.0001) reductions of 39.6% for plaque, 10.8% for gingivitis, and 65.4% for bleeding. No adverse events were observed or reported. The results of this pilot study suggest that three weeks of conventional use may be an adequate duration to demonstrate effectiveness of an essential oil-containing dentifrice. Confirmation of these results in a duplicate study is desirable to assess the reliability of the model. Furthermore, the utility of this model to determine the effects of formula modifications to the antiplaque and antigingivitis activity of active agents needs to be explored.
本项初步临床研究旨在评估一种短期刷牙模型的效用，该模型用于评估含精油牙膏配方对龈上菌斑和牙龈炎的抑制作用。42名符合条件的受试者进入并完成了这项双盲、平行组对照研究。在基线时，对受试者进行口腔软硬组织检查，并对菌斑、牙龈炎和出血情况进行视觉和侵入性评分。受试者接受龈上洁治，并被随机分配至含精油的实验牙膏组或其赋形剂对照组。受试者在无人监督的情况下每天刷牙两次，每次一分钟，持续三周，之后重复所有临床检查。所有检查均由一名合格且经过校准的检查人员进行。采用协方差分析比较三个结局变量组间均值。与赋形剂对照组相比，实验牙膏在统计学上使菌斑减少了39.6%、牙龈炎减少了10.8%、出血减少了65.4%（p < 0.0001）。未观察到或报告有不良事件。这项初步研究结果表明，三周的常规使用时间可能足以证明含精油牙膏的有效性。为评估该模型的可靠性，需要在重复研究中证实这些结果。此外，还需要探索该模型在确定配方改良对活性剂防菌斑和抗牙龈炎活性影响方面的效用。
