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临床试验/NCT01236950
NCT01236950已完成不适用

Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.

University of Lisbon1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Loe & Silness Gingival Index (1963)

研究概览

简要总结

The use of mouthrinses may be of relevance as a complement to daily dental hygiene procedures, especially for patients who do not comply with a proper mechanical removal of dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study hypothesis states that there are no differences between the mouthrinses on the reduction of gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus mutans, Lactobacillus, aerobic and anaerobic bacteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient at the dental hygiene clinic of Faculdade de Medicina Dentária
  • Signature of consent form
  • Have, at least, two quadrant with 6 teeth each
  • Gingival Index at baseline less than 3
  • Presence of dental plaque

排除标准

  • Use of a mouthrinse
  • Dental Hygiene appointment in the past 6 months
  • Use of antibiotics in teh past 3 months
  • Presence of extensive caries and fractures of teeth

研究组 & 干预措施

Delmopinol mouthrinse

Experimental

Subjects use the delmopinol mouthrinse

干预措施: Delmopinol mouthrinse (Drug)

Essential oils mouthrinse

Experimental

Subjects using the essential oils mouthrinse

干预措施: Essential oils mouthrinse (Drug)

结局指标

主要结局

Loe & Silness Gingival Index (1963)

时间窗: change from baseline in gingival index at two weeks

data collected at the begining of the study and two weeks after mouthrinse usage.

Quigley, Hein & Turesky Dental Plaque Index (1970)

时间窗: change from baseline in plaque index at two weeks

data collected at the begining of the study and two weeks after mouthrinse usage.

次要结局

  • Streptococcus mutans CFU(change from baseline in CFU counts at two weeks)
  • Lactobacillus CFU(change from baseline in CFU counts at two weeks)
  • Aerobic and anaerobic oral bacteria CFU(change from baseline in CFU counts at two weeks)

研究者

申办方类型
Other

研究点 (1)

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