A Clinical Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Loe-Silness
研究概览
简要总结
The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva
详细描述
This parallel design clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva.
The effects of the test toothpaste will be compared to a commercially available fluoride dentifrice that will serve as a control.
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
- •Male and female subjects, ages 18-70, inclusive.
- •Subject is available during study duration and has no allergies to oral hygiene formulations.
- •A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- •A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
- •Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more [Turesky Modification of Quigley-Hein] and gingivitis index of 1.0 or more [Loe-Silness].
排除标准
- •Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
- •History of dental prophylaxis or treatments in the past month or during study duration.
- •History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
- •Subjects scheduled for medical procedures for the duration of the study.
- •Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
- •History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
- •History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
- •History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- •Oral soft tissue pathology.
- •History of active or severe periodontal disease and loose teeth.
- •Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
- •Fixed or removable orthodontic appliance or removable partial dentures.
- •Self-reported pregnancy or lactation.
- •Subjects known to be an alcoholic, or a recovering alcoholic.
研究组 & 干预措施
Test 1 Toothpaste
Instructed to brush will full ribbon, 2x day/2 min with toothpaste
干预措施: stannous fluoride toothpaste (Drug)
Test 2 toothpaste
Instructed to brush will full ribbon, 2x day/2 min with toothpaste
干预措施: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste (Drug)
结局指标
主要结局
Loe-Silness
时间窗: baseline, 2 week and 4 week
gingivitis index of 1.0 or more
Turesky Modification of Quigley-Hein
时间窗: baseline, 2 week and 4 week
whole mouth scores of dental plaque of 1.5 or more
次要结局
未报告次要终点