Impact of the Daily Consumption of Herbal Pralines on Parameters of Oral Health in Crew Members of a Naval Ship at Sea - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- bleeding on probing (BoP)
研究概览
简要总结
This randomized, double-blinded, placebo-controlled two-arm, parallel group clinical trial is designed to evaluate the impact of the consumption of two herbal pralines containing 200 mg nitrate on clinical signs of gingival inflammation (Bleeding on probing) without an accompanied professional mechanical plaque removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •age 18 to 65 years,
- •minimum of 20 % of the measure points showing a manifest bleeding after probing,
- •no periodontal maintenance therapy within the past 4 months,
- •a minimum of 10 remaining natural teeth
排除标准
- •history of drug / alcohol abuse,
- •systemic intake of antibiotics < 6 months prior to the study period,
- •regular use of anti-inflammatory drugs,
- •regular use of antibacterial mouthwashes,
- •known allergic reactions to any ingredient in the experimental pralines
- •mean arterial blood pressure MAD <80mmHg
- •known allergies and intolerances to any of the ingredients of the experimental pralines
研究组 & 干预措施
verum
pralines containing nitrate 3x day (200mg nitrate per day)
干预措施: herbal nitrate Pralines with nitrate (Dietary Supplement)
placebo
pralines without nitrate
干预措施: herbal nitrate Pralines without nitrate (Dietary Supplement)
结局指标
主要结局
bleeding on probing (BoP)
时间窗: 28 days
observed percentage of probing sites being positive for bleeding on probing
bleeding on probing (BoP)
时间窗: baseline
observed percentage of probing sites being positive for bleeding on probing
bleeding on probing (BoP)
时间窗: 14 days
observed percentage of probing sites being positive for bleeding on probing
次要结局
- Periodontal inflamed surface area (PISA) mm2(Day 28)
- Salivary nitrate levels(Day 28)
- Gingiva Index (GI)(Day 28)
- saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)(day28)
- composition of the oral microbiome (subgingival)(day 28)
- Short-term Sick Leave(Day 28)
- saliva PH levels(Day 28)
- Plaque Control Record (PCR) according to O´Leary(Day 28)
- Pocket probing depth(Day 28)
- Periodontal inflamed surface area (PISA)(Day 14)
- Salivary nitrite levels(Day 28)
- Bacteria relevant to caries in saliva(Day 28)
- composition of the oral microbiome (subgingival)(baseline)
- composition of the oral microbiome (subgingival)(day 14)
- Plaque Control Record (PCR) according to O´Leary(Baseline)
- Plaque Control Record (PCR) according to O´Leary(Day 14)
- Gingiva Index (GI)(Baseline)
- Gingiva Index (GI)(Day 14)
- Pocket probing depth(Baseline)
- Pocket probing depth(Day 14)
- Periodontal inflamed surface area (PISA)(Baseline)
- Short-term Sick Leave(baseline)
- Short-term Sick Leave(Day 14)
- Salivary nitrate levels(Baseline)
- Salivary nitrate levels(Day 14)
- Salivary nitrite levels(Baseline)
- Salivary nitrite levels(Day 14)
- saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)(baseline)
- saliva buffer capacity ( the ability of a buffer solution to resist a change in pH)(day14)
- saliva PH levels(baseline)
- saliva PH levels(Day 14)
- Bacteria relevant to caries in saliva(Baseline)
- Bacteria relevant to caries in saliva(Day 14)
研究者
Dr. Yvonne Jockel-Schneider
Prof.Dr.
Wuerzburg University Hospital