Intraoral Appliance (IOA) Model Evaluating the Efficacy of Three Dentifrices on Enamel Lesion Remineralization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Percent Surface Microhardness Recovery (%SMHR) [Time Frame: End of each 9-day test period (three test periods in total)]
研究概览
简要总结
This single-center, randomized, double-blind, three-period crossover in situ study evaluated the enamel remineralization potential and fluoride bioavailability of three dentifrices-one fluoride-free negative control, one positive control with 0.243% sodium fluoride, and one investigational dentifrice containing 0.243% sodium fluoride and 20% sodium bicarbonate. Healthy adult subjects wore a palatal acrylic appliance containing demineralized enamel specimens for three 9-day treatment periods, during which in vivo brushing/slurry exposure and ex vivo sucrose challenges were performed. Outcomes included percent surface microhardness recovery (%SMHR) and post-treatment enamel fluoride concentration.
详细描述
This in situ intraoral appliance (IOA) model evaluates anticaries potential by exposing demineralized enamel specimens to oral conditions while allowing for ex vivo treatment assessments. Subjects wore acrylic palatal appliances containing four enamel specimens covered with steel gauze to promote plaque formation. Each of the three treatment periods lasted nine days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 4-day fluoride-free washout preceded each period. Post-treatment specimens were analyzed for %SMHR and enamel fluoride concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 years
- •Good general and oral health
- •Normal unstimulated salivary flow (≥1.5 mL/5 min)
- •Functional dentition
- •Oral conditions adequate to support the palatal appliance
- •Ability to comply with brushing, slurry, appliance wear, and sucrose challenge procedures
排除标准
- •Inability to tolerate appliance
- •Oral pathology that interferes with participation
- •Antibiotic use that violates withdrawal criteria
- •Use of fluoride toothpaste during washout
- •Participation in another appliance study in the past 4 weeks
研究组 & 干预措施
Negative Control Toothpaste
Fluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing during each test day.
干预措施: Negative Control Toothpaste (Drug)
Comparator
干预措施: Active Comparator (Drug)
Test Toothpaste
干预措施: Test Toothpaste (Drug)
结局指标
主要结局
Percent Surface Microhardness Recovery (%SMHR) [Time Frame: End of each 9-day test period (three test periods in total)]
时间窗: End of each 9#day test period (three test periods in total)
Post-treatment fluoride concentration (µg F/g enamel)
时间窗: End of each 9-day test period (three test periods in total
次要结局
未报告次要终点