A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
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
- Change From Baseline Air Challenge
研究概览
简要总结
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Provide written informed consent prior to participation and be given a signed copy of the informed consent form
- •Complete a confidentiality disclosure agreement
- •Be in good general health as determined by the Investigator/designee
- •Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.
排除标准
- •Self-reported pregnancy or nursing
- •Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- •Active treatment of periodontitis
- •Fixed facial orthodontic appliances
- •A history of kidney stones
- •Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
- •Any diseases or conditions that might interfere with the safe completion of the study
- •An inability to undergo any study procedures.
研究组 & 干预措施
oxalate liquid & gel plus SnF2 paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
干预措施: Potassium oxalate (Device)
oxalate liquid & gel plus SnF2 paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
干预措施: Stannous fluoride paste (Drug)
oxalate liquid & gel plus NaF paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
干预措施: Potassium oxalate (Device)
oxalate liquid & gel plus NaF paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
干预措施: Sodium fluoride paste (Drug)
结局指标
主要结局
Change From Baseline Air Challenge
时间窗: 60 days
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
次要结局
- Change From Baseline Visual Analog Scale(60 days)