Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Did Participants Notice a Difference in the Areas Noted?
研究概览
简要总结
This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •be at least 18 years of age
- •sign an informed consent form and be given a copy
- •be in good general health as determined by the Investigator/designee
- •agree to not participate in any other oral care study for the duration of this study
- •agree to return for scheduled visits and follow all study procedures
- •have at least one tooth at risk for hypersensitivity.
排除标准
- •any medical condition requiring pre-medication prior to dental procedures
- •any diseases or conditions that might interfere with the subject safely completing the study
- •inability to undergo study procedures
- •a history of kidney stones
- •have self-reported pregnancy or nursing
- •known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, or potassium sorbate
研究组 & 干预措施
oxalate liquid, SnF2 paste
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
干预措施: Stannous fluoride paste (Drug)
potassium oxalate gel
potassium oxalate gel self applied
干预措施: Potassium Oxalate Gel (Device)
oxalate liquid, SnF2 paste
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
干预措施: Potassium Oxalate Liquid (Device)
结局指标
主要结局
Did Participants Notice a Difference in the Areas Noted?
时间窗: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
How Satisfied Were Participants With Treatment?
时间窗: up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Ease of Treatment at Home
时间窗: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
次要结局
未报告次要终点