The Efficacy of a Toothpaste to Reduce Sensitivity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 626
- 试验地点
- 1
- 主要终点
- Hypersensitivity Tactile(Yeaple Probe)
研究概览
简要总结
Hypersensitivity
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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects, ages: 12 years or older.
- •Availability for the eight-week duration of the study.
- •Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- •Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.
- •Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- •Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.
- •Good general health with no known allergies to products being tested.
- •Use of a non-desensitizing dentifrice for one month prior to entry into the study.
- •Signed Informed Consent Form.
排除标准
- •Gross oral pathology, chronic disease, or history of allergy to test products.
- •Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- •Sensitive teeth with a mobility greater than one.
- •Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- •Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
- •Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
- •Current participation in any other clinical study.
- •Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
- •Medical condition which prohibits not eating/drinking for 4 hours.
研究组 & 干预措施
A
sensitive toothpaste
干预措施: Triclosan, Silicon dioxide, fluoride (Drug)
B
Triclosan control toothpaste
干预措施: Triclosan, fluoride (Drug)
结局指标
主要结局
Hypersensitivity Tactile(Yeaple Probe)
时间窗: 4 weeks
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Hypersensitivity Tactile (Yeaple Probe)
时间窗: 8 weeks
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
次要结局
- Air Blast Hypersensitivity (4 Week)(4 weeks)
- Air Blast Hypersensitivity (8 Week)(8 weeks)