Effect of Probiotics on Oral Candida Colonization Level in Complete Denture Wearers (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in candida count
研究概览
简要总结
Forty-eight denture wearers with detectable levels of candida colonization without clinical symptoms will be randomly allocated into two groups: probiotics and placebo. All patients will take a daily dose of chewable tablets (probiotics or placebo according to the assigned group) for 8 weeks. Samples of mouth rinse will be collected from patients at baseline, 4 weeks from the beginning of the intervention, 8 weeks (the end of intervention), and after another 4 weeks for post-intervention follow up. Samples will be tested for both candida count and candida species identification
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Detectable levels of Candida in palatal mucosa without clinical symptoms of active candidiasis.
- •Completely edentulous arches with newly formed denture .
- •Patients with controlled hypertension, and diabetes will be included in this study as they are considered very common problems in the targeted population.
排除标准
- •Inability to understand/ follow the experimental procedures,
- •Administration of topic or systemic antifungal or antibacterial agents in the previous 60 days.
- •Consumption of probiotics.
- •GITdisorders.
- •Heartdisease.
- •Diseases that significantly influence immunity such as; kidney problems, head and neck cancer, or radiotherapy, AIDS, or immunosuppressive therapy.
- •Clinical manifestations of oral candidiasis.
结局指标
主要结局
Change in candida count
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Quantitative culture will be performed from mouth-rinse samples by inoculation onto the surface of Sabouraud dextrose agar plates with chloramphenicol, and subsequent aerobic incubation for 24 to 48 hours at 37°C.
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University