A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Loe-Silness Gingival Index
研究概览
简要总结
To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis.
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
- •Signed Informed Consent Form.
- •Male and female subjects aged 18-70 years, inclusive.
- •Availability for the twelve-week duration of the clinical research study.
- •Good general health based on the opinion of the study investigator
- •Minimum of 20 permanent natural teeth (excluding third molars).
- •Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
- •Initial mean plaque index of at least 0.6 as determined by Rustogi Modification of the Navy plaque index.
排除标准
- •Presence of orthodontic appliances;
- •Presence of partial removable dentures;
- •Oral pathology, chronic disease or tumor(s) of the soft or hard tissues of the oral cavity;
- •Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone);
- •Five or more carious lesions requiring immediate restorative treatment;
- •Use of anticonvulsants, sedatives, tranquilizers, anti-inflammatory or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- •Use of antibiotics any time during the one-month period prior to entry into the study;
- •Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) and/or on any prescription medicines that might interfere with the study outcome;
- •Participation in any other clinical study;
- •Self-reported pregnancy and/or breastfeeding;
- •Dental prophylaxis within the past three weeks prior to baseline examinations;
- •Current allergies and/or history of allergic reactions to oral care products, personal care consumer products, or any of their ingredients;
- •An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours;
- •Current smokers and/or a history of alcohol or drug abuse
研究组 & 干预措施
Test 2
instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided
干预措施: 0.454%Stannous fluoride toothpaste (Drug)
Test 2
instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided
干预措施: 0.022% Sodium Fluoride mouthwash (Drug)
Test 1
instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided
干预措施: 0.454%Stannous fluoride toothpaste (Drug)
Test 1
instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided
干预措施: 0.075% Cetylpyridinium Chloride (CPC) and 0.28% zinc lactatmouthwashe (Drug)
Test 3
instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided
干预措施: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste (Drug)
Test 3
instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided
干预措施: 0.022% Sodium Fluoride mouthwash (Drug)
结局指标
主要结局
Loe-Silness Gingival Index
时间窗: Baseline, 6-weeks, and 12-weeks
score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces
Rustogi Modification of the Navy Plaque Index
时间窗: Baseline, 6-weeks, and 12-weeks
a red disclosing solution will be used to make plaque visible and improve scoring accuracy. Subjects will be instructed to swish approximately 10 drops of the solution in their mouth for 10-15 seconds before expectorating.
次要结局
未报告次要终点