Clinical Investigation of Oral Malodor for Max Fresh Toothpaste Containing Zinc Citrate Versus a Commercially Available Regular Fluoride Toothpaste Using the Organoleptic Method: a Three-week Study in China
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Organoleptic Oral Malodor Evaluations
研究概览
简要总结
The objective of this three-week clinical research study is to evaluate oral malodor for a toothpaste containing zinc citrate as compared to a commercially available regular fluoride toothpaste using the organoleptic method.
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
- •Adults aged 18-70 years, inclusive.
- •Availability for the full three-week duration of the study.
- •Good general health.
- •Initial mean oral malodor (organoleptic) score ≥ 6.0 and ≤ 8.
- •Signed informed consent form.
排除标准
- •Presence of orthodontic bands.
- •Tumors of the soft or hard tissues of the oral cavity.
- •Advanced periodontal disease (e.g., purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- •Five (5) or more carious lesions requiring immediate restorative treatment.
- •Use of antibiotics within one (1) month prior to study entry.
- •Participation in any other clinical study or test panel within one (1) month prior to study entry.
- •Dental prophylaxis within two (2) weeks prior to the initial examination.
- •History of allergies to oral care/personal care products or their ingredients.
- •Use of prescription medications that might interfere with study outcomes.
- •Medical condition that prevents fasting (no food or drink) for up to four (4) hours.
- •History of drug and/or alcohol abuse.
- •Pregnant or lactating (self-reported).
研究组 & 干预措施
Test 1
Subjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks.
干预措施: Max Fresh Toothpaste (Drug)
Control toothpaste
Subjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks.
干预措施: Colgate Cavity Protection Toothpaste (Drug)
结局指标
主要结局
Organoleptic Oral Malodor Evaluations
时间窗: baseline, 3 weeks
Baseline evaluations will be conducted in the morning. On the morning of the evaluation, subjects must refrain for at least six (6) hours from all oral hygiene (brushing, rinsing, and flossing) and from eating and drinking prior to the scheduled visit. At baseline, the mean of the scores from the four judges will constitute each subject's baseline oral malodor score. Subjects with a baseline mean score ≥ 6.0 and ≤ 8.4 will be enrolled
organoleptic method
时间窗: baseline, 3 weeks
assessed using the 1-9 organoleptic scale
次要结局
未报告次要终点