跳至主要内容
临床试验/NCT02935322
NCT02935322已完成4 期

Interaction Chlorhexidine-fluoride - a 4-day and 6-week Randomised Clinical Mouthrinse Study

University of Oslo0 个研究点目标入组 32 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
32
主要终点
Plaque index

研究概览

简要总结

The aim of the present study was to study if there are interactions and reduced clinical effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.

详细描述

The investigation assessed the clinical effect of a mouthrinse containing chlorhexidine (CHX) and sodium fluoride (NaF) during a 4-day period of non-brushing and a 6-week period of brushing. Two studies were designed as double-blind, randomized, cross-over clinical trials. In study I, 16 healthy subjects rinsed twice daily for 1 min during 4 days of no tooth brushing with four mouthrinse solutions: 1) 0.12% CHX + 0.2% NaF, 2) 0.2% NaF, 3) 0.12% CHX, and 4) placebo. In study 2, 16 healthy subjects rinsed with the same four solutions twice daily after tooth brushing during a 6-week period. Primary outcomes were plaque formation and gingivitis. Secondary outcomes were fluoride retention and microbiological parameters in plaque and saliva (total bacterial counts and mutans streptococci, lactobacilli and streptococci sanguinis counts). One way analyses of variance with post hoc Student-Newman-Keul´s statistical test was performed for comparisons between mouthrinses. Intragroup changes over time were analyzed with a paired t-test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female subjects, age 18-35 years
  • Good general health
  • No signs of periodontitis and caries
  • A minimum of 24 teeth with no extensive restorations
  • No current or planned dental treatment during the trial periods.

排除标准

  • Antibiotic treatment within 1 month prior to the start of the trial
  • Current medication with anti-inflammatory drugs
  • Use of antiseptic mouthrinses
  • Smokers and snuff user
  • Use of chewing gums

研究组 & 干预措施

0.12 % chlorhexidine + 0.2 % NaF mouthrinse

Active Comparator

A mouthrinse combining chlorhexidine and NaF

干预措施: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse (Drug)

0.2 % NaF mouthrinse

Active Comparator

A mouthrinse containing NaF

干预措施: 0.2 % NaF mouthrinse (Drug)

0.12% chlorhexidine mouthrinse

Active Comparator

A mouthrinse containing chlorhexidine

干预措施: 0.12% chlorhexidine (Drug)

Placebo mouthrinse

Placebo Comparator

A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride

干预措施: Placebo (Other)

结局指标

主要结局

Plaque index

时间窗: Day 42

Gingivitis index

时间窗: Day 42

次要结局

  • Total bacterial counts in dental plaque and saliva(Day 42)
  • Streptococcus sanguis counts in dental plaque and saliva(Day 42)
  • Mutans streptococci counts in dental plaque and saliva(Day 4)
  • Lactobacilli counts in dental plaque and saliva(Day 42)
  • Streptococcus sanguinis counts in dental plaque and saliva(Day 42)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar Villa

PhD

University of Oslo

相似试验

Interaction Between Chlorhexidine and Fluoride | 临床试验