Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Surface loss
研究概览
简要总结
The goal of this clinical trial is to learn if a new toothpaste can prevent enamel erosion in healthy adults. Researchers will compare the test toothpaste to a control toothpaste to see if there is a difference in erosion levels. Participants will brush twice a day for two minutes with their assigned toothpaste.
详细描述
The objective of this clinical study is to assess the efficacy of New Toothpaste Containing SnF as compared to commercially available toothpaste in the reduction of enamel erosion over a ten (10) days period. This investigation will be a randomized, double-blinded, single-center, parallel clinical study. Subjects will be randomly assigned to one of the two study groups, and will be instructed to use their assigned toothpaste for a period of ten (10) days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign an Informed Consent Form;
- •Male or female 18 to 70 years of age, inclusive;
- •Be in good general health as determined by the study investigators;
- •Available for the eighteen (18) days duration of the study;
- •Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary saliva examination;
- •Have healthy salivary pH (unstimulated saliva pH 6.8-7.8) ascertained from a preliminary saliva test;
- •Must be able to accept a well-fitting removable intraoral appliance bearing at least two enamel specimens.
排除标准
- •Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
- •Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
- •Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months;
- •Obvious signs of dental erosion Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
- •Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics, or medication which alters salivary flow
- •Participation in any other oral clinical study for the duration of this study
- •Self-reported pregnancy and/or currently breastfeeding;
- •Allergies to oral care products, personal care consumer products, and/or their ingredients;
- •Medical condition which prohibits not eating/drinking for 4 hours.
研究组 & 干预措施
Test
Participants will brush with a new toothpaste Containing SnF for two minutes twice daily.
干预措施: New Toothpaste Containing SnF (Drug)
Control
Participants will brush with a regular fluoride toothpaste for two minutes twice daily.
干预措施: Fluoride Toothpaste (Drug)
结局指标
主要结局
Surface loss
时间窗: From baseline to the end of treatment at 10 days.
Depth of surface loss in an enamel block worn on a dental retainer by the participant, as determined by an optical profilometer.
次要结局
未报告次要终点