Harper D S, Mueller L J, Fine J B, Gordon J, Laster L L
Fairleigh-Dickinson University, Oral Health Research Center, Hackensack, NJ.
J Periodontol. 1990 Jun;61(6):352-8. doi: 10.1902/jop.1990.61.6.352.
The efficacy of combined use of toothpaste and oral rinse containing sanguinaria extract and zinc chloride was compared to placebo products in a 6-month clinical trial. Sixty subjects with moderate levels of plaque and gingivitis were randomly assigned to active and placebo groups. Noninvasive measures of plaque and gingivitis were assessed at baseline and at 2, 6, 8, 14, 20, and 28 weeks. Bleeding on probing was measured at baseline and 6, 14, and 28 weeks. Active group scores were significantly lower (P less than .0001) than placebo scores at each post-baseline time point for all indices, with the exception of plaque at 2 weeks. The 28 week active group scores were 21% lower than the placebo group for plaque, 25% lower for gingivitis, and 43% lower for bleeding on probing. No dental staining or taste alteration was reported in the active group. Three of 30 active group subjects exhibited minor soft tissue irritations that resolved spontaneously without discontinuation of product use. Results indicate that the test products showed good levels of safety and efficacy when administered in a combined use regimen for 6 months.
在一项为期6个月的临床试验中,将含有血根碱提取物和氯化锌的牙膏与漱口水联合使用的效果与安慰剂产品进行了比较。60名菌斑和牙龈炎程度中等的受试者被随机分配到活性组和安慰剂组。在基线以及第2、6、8、14、20和28周时,对菌斑和牙龈炎进行非侵入性测量。在基线以及第6、14和28周时测量探诊出血情况。除了在2周时的菌斑指数外,活性组在每个基线后时间点的所有指标得分均显著低于安慰剂组(P小于0.0001)。在第28周时,活性组的菌斑得分比安慰剂组低21%,牙龈炎得分低25%,探诊出血得分低43%。活性组未报告牙齿染色或味觉改变。30名活性组受试者中有3人出现轻微的软组织刺激,自行缓解,未停止使用产品。结果表明,试验产品在联合使用6个月的方案中显示出良好的安全性和有效性。