Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health in a Group of Young Adults: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Turesky modification of Quigley-Hein plaque index
研究概览
简要总结
This study evaluates the addition of a mouth rinse containing sea salt, xylitol and lysozyme to standardized oral health practices on biofilm formation and gingival health in a group of young adults.
详细描述
The purpose of this study is to evaluate a new sea salt mouth rinse containing xylitol and the antibacterial enzyme, lysozyme on biofilm formation and gingival health in a group of young adults. Xylitol is a well-established non-sugar sweetener and an anti-caries agent. The use of this polyol results in loosely adherent biofilms by reducing the amount of extracellular lipopolysaccharides and lipoteichoic acids, facilitating its easy removal by mechanical means. Lysozymes are antibacterial proteins that hydrolyze the linkage between N-acetylmuramic acid and N-acetylglucosamine of peptidoglycan in the cell wall of Gram + bacteria effectively limiting growth.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy
- •No orthodontic bands
- •An anticipated ability to attend the two scheduled visits
排除标准
- •Significant medical condition (including but not limited to, poorly controlled diabetes mellitus, rheumatic heart disease or clinically significant heart murmur)
- •Pregnancy
- •Recent history of, or ongoing, antibiotic therapy
研究组 & 干预措施
Sea Salt Mouth Rinse
干预措施: Sea Salt Mouth Rinse (Other)
Sea Salt Mouth Rinse
干预措施: Standardized Oral Health Practices (Other)
Standardized Oral Health Practices
干预措施: Standardized Oral Health Practices (Other)
结局指标
主要结局
Turesky modification of Quigley-Hein plaque index
时间窗: Change from Baseline at 1 Month
Evaluation of plaque scores on six representative teeth: 16, 21, 24, 36, 41 \& 44, using an index that evaluates the plaque revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5, defined by G. A. Quigley and J. W. Hein in 1962 and modified by S. Turesky, N. D. Gilmore, and I. Glickman in 1970.
Presence or absence of gingival bleeding
时间窗: Baseline and 1 Month
Presence or absence of gingival bleeding on gentle probing to determine gingival health
次要结局
未报告次要终点
研究者
Jay Hoover
Principal Investigator
University of Saskatchewan