Clinical Investigation to Assess the Efficacy of a Toothpaste Containing 8% Arginine as Compared to Colgate Cavity Protection Toothpaste in the Reduction of Dentinal Hypersensitivity.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Tactile stimulation by the Yeaple Probe
研究概览
简要总结
The objective of this clinical investigation is to assess the efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over an eight (8) week 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
- 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 eight (8) weeks 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
Test 1 toothpaste
During this clinical study, you will be assigned to one of the two study groups. You will be provided with a toothpaste and toothbrush for at home use. You will be instructed to brush your teeth twice daily for one (1) minute each time. You are to repeat the same procedures for the duration of the study.
干预措施: TOMs of Maine Sensitive SLS Free Xtra Fresh (Device)
Test 2 toothpaste
During this clinical study, you will be assigned to one of the two study groups. You will be provided with a toothpaste and toothbrush for at home use. You will be instructed to brush your teeth twice daily for two (2) minute each time. You are to repeat the same procedures for the duration of the study.
干预措施: Colgate Cavity protection toothpaste (Drug)
结局指标
主要结局
Tactile stimulation by the Yeaple Probe
时间窗: baseline, 3 day, 4 weeks, 8 weeks
Hypersensitivity defined by a response score in the range of 10-50 grams of force.
Air blast stimulation
时间窗: baseline, 3 day, 4 weeks, 8 weeks
Jet of air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F \[± 3°F\]) \[hypersensitivity defined by a response score of 2 or 3 on the Schiff Cold Air Sensitivity Scale
次要结局
未报告次要终点