Intra Oral 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
- 30
- 试验地点
- 1
- 主要终点
- Percent Surface Microhardness Recovery (%SMHR)
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: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate (KNO₃), and 20% sodium bicarbonate. Adult subjects wore acrylic palatal appliances containing demineralized enamel specimens for three 7-day treatment periods, each preceded by a 5-day fluoride-free washout. Primary outcomes were percent surface microhardness recovery (%SMHR) and 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 seven days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 5-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 saliva flow (≥1.5 mL unstimulated saliva in 5 minutes)
- •≥16 teeth and functional maxillary dentition to support palatal appliance
- •Agree to abstain from other oral care products and preventive dental procedures during study
- •No advanced periodontal disease, no visible untreated caries
- •If female, not pregnant or breastfeeding (self-reported)
- •No significant oral soft tissue pathology; no peri/oral piercings; no removable partial dentures
- •No antibiotics or immunosuppressives within 30 days of screening
- •No palatal torus; no medical condition that would interfere with safety
- •No allergy or significant adverse events to impression materials, acrylics, or common oral product
排除标准
- •Unable to tolerate appliance or comply with procedures
- •Oral pathology that interferes with participation
- •Use of fluoride toothpaste during washout periods
- •Participation in another appliance study within the last 4 week
研究组 & 干预措施
Negative Control Toothpaste
Fluoride-free dentifrice (0 ppm fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.
干预措施: Negative Control Toothpaste (Drug)
Comparator
Sodium fluoride dentifrice (0.243% sodium fluoride). Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.
干预措施: Active Comparator (Drug)
Test Toothpaste
Test dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate, and 20% sodium bicarbonate. Used for twice-daily brushing and slurry swishing per protocol during each 7-day test period.
干预措施: Test toothpaste (Drug)
结局指标
主要结局
Percent Surface Microhardness Recovery (%SMHR)
时间窗: End of each 7-day test period (three periods total)
Enamel Fluoride Concentration (EFU)
时间窗: End of each 7-day test period (three periods total)
Post-treatment enamel fluoride concentration (µg F/cm³)
次要结局
未报告次要终点