Interaction Chlorhexidine-fluoride - a 4-day and 6-week Randomised Clinical Mouthrinse Study
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
- 是
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
A mouthrinse combining chlorhexidine and NaF
干预措施: 0.12 % chlorhexidine + 0.2 % NaF mouthrinse (Drug)
0.2 % NaF mouthrinse
A mouthrinse containing NaF
干预措施: 0.2 % NaF mouthrinse (Drug)
0.12% chlorhexidine mouthrinse
A mouthrinse containing chlorhexidine
干预措施: 0.12% chlorhexidine (Drug)
Placebo mouthrinse
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)
