Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Mineral Change (delta Z)
研究概览
简要总结
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female subjects 18 to 50 years inclusive
- •Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
- •Willing to wear retainer 24 hours per day
- •No active, unrestored cavities
- •Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
- •Available throughout entire study
- •Willing to use only assigned products for oral hygiene throughout the duration of the study
- •Must give written informed consent
- •Must be in good general health
- •No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
排除标准
- •Advanced periodontal disease
- •Medical condition which requires premedication prior to dental visits/procedures
- •Not enough teeth to secure the oral retainer
- •Diseases of the soft or hard oral tissues
- •Wear an Orthodontic retainer(s)
- •Impaired salivary function
- •Current use drugs that can affect salivary flow
- •Use antibiotics one (1) month prior to or during this study
- •Positive urine test for pregnancy (a urine pregnancy test will be performed on female subjects of child-bearing potential)
- •Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
- •Use tobacco products
- •Allergic history to common toothpaste ingredients
- •Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history
研究组 & 干预措施
Fluoride Free toothpaste
Fluoride free (0%), silica based toothpaste
干预措施: Fluoride Free toothpaste (Drug)
Fluoride Free toothpaste
Fluoride free (0%), silica based toothpaste
干预措施: 1.1% Fluoride toothpaste (Drug)
Fluoride Free toothpaste
Fluoride free (0%), silica based toothpaste
干预措施: 0.243% Fluoride toothpaste (Drug)
1.1% Fluoride toothpaste
Prevident 5000 Plus, silica based toothpaste
干预措施: Fluoride Free toothpaste (Drug)
1.1% Fluoride toothpaste
Prevident 5000 Plus, silica based toothpaste
干预措施: 1.1% Fluoride toothpaste (Drug)
1.1% Fluoride toothpaste
Prevident 5000 Plus, silica based toothpaste
干预措施: 0.243% Fluoride toothpaste (Drug)
0.243% Fluoride Toothpaste
silica based fluoride toothpaste
干预措施: Fluoride Free toothpaste (Drug)
0.243% Fluoride Toothpaste
silica based fluoride toothpaste
干预措施: 1.1% Fluoride toothpaste (Drug)
0.243% Fluoride Toothpaste
silica based fluoride toothpaste
干预措施: 0.243% Fluoride toothpaste (Drug)
结局指标
主要结局
Mineral Change (delta Z)
时间窗: 2 weeks (from Baseline)
Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of brushing while wearing the study oral retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions, vol % µm). These post use values will be compared to the baseline values to give a delta mineral change ( ΔZ).
次要结局
未报告次要终点