A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Modified Proximal Plaque Index (MPPI)
研究概览
简要总结
Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.
Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period. Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •participants between 18 and 65 years
- •no severe periodontitis
- •informed consent
排除标准
- •handicapped participants
- •allergies against mouth rinses
研究组 & 干预措施
toothbrushing plus rinsing
0.06% CHX + 0.025% NaF plus toothbrushing and alcohol-containing mouth rinsing
干预措施: alcohol-containing mouth rinsing (Other)
alcohol-free experimental mouth rinse
0.06% CHX + 0.025% NaF plus toothbrushing
干预措施: alcohol-free experimental mouth rinse (Other)
toothbrushing and rinsing
0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free, mouth rinsing
干预措施: alcohol-free experimental mouth rinse (Other)
toothbrushing alone
negative control
结局指标
主要结局
Modified Proximal Plaque Index (MPPI)
时间窗: Eight weeks
次要结局
未报告次要终点
研究者
PD Dr. A. Rainer Jordan
Head of Section Preclinical Dentistry
University of Witten/Herdecke
