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临床试验/NCT00981825
NCT00981825已完成3 期

Efficacy of Salivary Bacteria and Post Brushing

Colgate Palmolive1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
22
试验地点
1
主要终点
CFU (Colony Forming Units)

研究概览

简要总结

Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
  • No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

排除标准

  • Medical condition which requires pre-medication prior to dental procedures/visits
  • Medical condition which precludes eating/drinking for 12 hrs.
  • History of allergy to common dentifrice ingredients
  • Subjects unable or unwilling to sign the informed consent form.
  • Moderate or advanced periodontal disease.
  • 2 or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that can currently affect salivary flow
  • Current use of antibiotics
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #
  • Pregnant or nursing women.
  • Participation in any other clinical study within 30 days prior to enrollment into this study.
  • Use of tobacco products
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)

研究组 & 干预措施

A

Placebo Comparator

fluoride toothpaste control

干预措施: Fluoride (Drug)

B

Active Comparator

triclosan/fluoride toothpaste

干预措施: Triclosan/Fluoride (Drug)

结局指标

主要结局

CFU (Colony Forming Units)

时间窗: 4 hours

Total number of salivary bacterial colony forming units (lower number = less colonies present)

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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