Clinical Study to Assess the Efficacy of a Dentifrice Containing Stannous Fluoride as Compared to a Commercially-available Potassium-based Toothpaste and a Regular Fluoride Toothpaste on the Reduction of Dentinal Hypersensitivity.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Tactile dentin hypersensitivity
研究概览
简要总结
The objective of this clinical study is to assess the efficacy of a dentifrice containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially-available potassium-based toothpaste (Sensodyne Extra Whitening Toothpaste, GlaxoSmithKline Co., UK) and a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over a seven (7) day period.
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
- Triple (Participant, Care Provider, Investigator)
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 seven (7) days duration of the study;
- •Must present two (2) sensitive teeth which must meet ALL of the following criteria:
- •Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession;
- •Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10- 50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA);
- •Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale
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;
- •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;
- •Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics;
- •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
Group I
Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
干预措施: Colgate SNF (Drug)
Group II
Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
干预措施: Sensodyne Extra Whitening (Drug)
Group III
Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush
干预措施: Colgate Fluoride (CDC) (Drug)
结局指标
主要结局
Tactile dentin hypersensitivity
时间窗: Baseline, 1-Day, 3-Days and 7-Days
Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10- 50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA)
Air blast dentin hypersensitivity
时间窗: Baseline, 1-Day, 3-Days and 7-Days
Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
次要结局
未报告次要终点