Lisante Toni Anne, McGuire J A, Williams K P
Johnson & Johnson Consumer & Personal Products Worldwide, Morris Plains, NJ, USA.
J Clin Dent. 2013;24(1):5-11.
The objectives of this clinical trial were to determine the tooth staining potential as measured by the Macpherson Modification of the Lobene Stain Index, and degree of taste alteration of four currently marketed mouthrinses when used over a 12-week period.
This investigation consisted of a 12-week, observer-blind, single-center, randomized comparison of five parallel groups of subjects. One-hundred and seventy-one subjects granting their informed consent completed the trial. Subjects were randomized to one of four currently marketed mouthrinses Crest PRO-HEALTH Rinse (CPH), Cēpacol (C), Scope (S), Viadent ADVANCED CARE (V), or brushing alone (BA) with a currently marketed fluoride toothpaste. Upon randomization, subjects received a baseline stain score and then a prophylaxis to remove all extrinsic stain. Clinical assessments were repeated after six weeks and three months of product use, and subjects were asked to complete a questionnaire after the first use, at day 4, day 14, at six weeks, and 12 weeks to assess potential taste alteration.
CPH and C demonstrated significantly (p < 0.001) more extrinsic stain after six weeks of use, and CPH, C (p < 0.001), and S (p = 0.01) after 12 weeks of use versus brushing alone with fluoride toothpaste. V was not significantly different from brushing alone at either time point. After six weeks of using the product as directed, up to 53% of subjects using CPH experienced taste interference for up to three hours post-rinse.
The results of this study demonstrated that regular use of CPH and C mouthrinses resulted in extrinsic stain accumulation after six weeks, with increased accumulation after 12 weeks versus brushing alone.
本临床试验的目的是通过洛贝内染色指数的麦克弗森修正法来测定牙齿染色潜力,并确定四种市售漱口水在12周使用期内的味觉改变程度。
本研究包括一项为期12周、观察者盲法、单中心、五组平行受试者的随机对照试验。171名签署知情同意书的受试者完成了试验。受试者被随机分为四组,分别使用四种市售漱口水佳洁士全优护理漱口水(CPH)、西帕科尔漱口水(C)、Scope漱口水(S)、维雅登高级护理漱口水(V),或仅使用市售含氟牙膏刷牙(BA)。随机分组后,受试者接受基线染色评分,然后进行洁治以去除所有外源性染色。在使用产品六周和三个月后重复进行临床评估,并要求受试者在首次使用后、第4天、第14天、六周和12周完成问卷,以评估潜在的味觉改变。
使用六周后,CPH和C漱口水的外源性染色显著更多(p < 0.001),使用12周后,CPH、C漱口水(p < 0.001)和S漱口水(p = 0.01)的外源性染色显著多于仅使用含氟牙膏刷牙。在两个时间点,V漱口水与仅刷牙相比均无显著差异。按照指示使用产品六周后,使用CPH漱口水的受试者中,高达53%的人在漱口后长达三小时内经历了味觉干扰。
本研究结果表明,定期使用CPH和C漱口水六周后会导致外源性染色积累,与仅刷牙相比,12周后染色积累增加。