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临床试验/NCT01811615
NCT01811615已完成不适用

A Clinical Study to Investigate the Efficacy of New Alcohol Free Mouthrinses

University of Witten/Herdecke1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Experimental

0.06% CHX + 0.025% NaF plus toothbrushing

干预措施: alcohol-free experimental mouth rinse (Other)

toothbrushing and rinsing

Experimental

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

No Intervention

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

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

PD Dr. A. Rainer Jordan

Head of Section Preclinical Dentistry

University of Witten/Herdecke

研究点 (1)

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