Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse
研究概览
简要总结
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.
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
- Single (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
- 是
入选标准
- •An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
- •No current active caries or periodontal disease that may compromise the study or the health of the subjects
- •A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute
排除标准
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
研究组 & 干预措施
Test Dentifrice + Test Mouth Rinse (MR)
Test fluoride dentifrice and test fluoride MR
干预措施: Sodium fluoride (Drug)
Test Dentifrice + Sterile Water Rinse
Test fluoride dentifrice and sterile water rinse
干预措施: Sodium fluoride (Drug)
Test Dentifrice + Sterile Water Rinse
Test fluoride dentifrice and sterile water rinse
干预措施: Sterile water (Drug)
Placebo Dentifrice + Test MR
Placebo dentifrice and test fluoride rinse
干预措施: Sodium fluoride (Drug)
Reference Dentifrice + Sterile Water Rinse
Marketed fluoride dentifrice with sterile water rinse
干预措施: Sodium fluoride (Drug)
Reference Dentifrice + Sterile Water Rinse
Marketed fluoride dentifrice with sterile water rinse
干预措施: Sodium monoflurophosphate (Drug)
Reference Dentifrice + Sterile Water Rinse
Marketed fluoride dentifrice with sterile water rinse
干预措施: Sterile water (Drug)
Placebo Dentifrice + Sterile Water Rinse
Placebo dentifrice and sterile water rinse
干预措施: Sterile water (Drug)
结局指标
主要结局
Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse
时间窗: Baseline, 4 hours post treatment in each treatment period
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.
次要结局
- Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse(Baseline, 4 hours post treatment in each treatment period.)