Impact of the Daily Consumption of L.Reuteri-containing Lozenges on Oral and General Health in Crew Members of a Naval Ship at Sea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Bleeding on Probing
研究概览
简要总结
This study is designed to evaluate the impact of the regular consumption of probiotic Lactobacillus reuteri-containing lozenges over a period of 42 days on parameters of oral and general health in crew members of a naval ship at sea.
详细描述
Probiotic strains of Lactobacillus reuteri have demonstrated a significant impact on the composition of the oral and intestinal microbiome as well as modulating the host response in several clinical trials and in vitro experiments.
This two-arm double blind placebo controlled clinical trial will evaluate the impact of the regular consumption of L.reuteri-containing lozenges over a period of 42 days on parameters of oral and general health in crew members of a naval ship at sea.
2 x 36 healthy study subjects will be recruited from the crew members of the ship.
At baseline and at the end of the study (day 42) the following parameters will be recorded at the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44):
Bleeding on Probing (BoP) as the primary outcome
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Minimum of 12 natural teeth
排除标准
- •Regular intake of antiinflammatory drugs affecting periodontal health (e.g. NSAIDs) Manifestation of systemic disease affecting periodontal health (e.g. diabetes) Use of antiseptic oral mouthrinses Drug/alcohol abuse
研究组 & 干预措施
Placebo lozenges
2x daily repeated intake of lozenges being void of Lactobacillus reuteri for 42 days.
干预措施: Placebo (Dietary Supplement)
Lactobacillus reuteri lonzenges
2x daily repeated intake of lozenges containing 10E9 CFU Lactobacillus reuteri each for 42 days
干预措施: Lactobacillus reuteri (Dietary Supplement)
结局指标
主要结局
Bleeding on Probing
时间窗: 42 days
Number of sites being positive for bleeding on probing on the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44) with 6 probing sites per tooth
次要结局
- Composition of the intestinal microbiome(42 days)
- Composition of the oral microbiome(42 days)
- Short-term sick leave(42 days)
- Gingival Index (GI)(42 days)
- Plaque Control Record (PCR)(42 days)
- Probing Pocket Depth (PPD)(42 days)
研究者
Prof. Dr. Ulrich Schlagenhauf
chairman Dept. of Periodontology
Wuerzburg University Hospital