3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
研究概览
简要总结
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.
详细描述
The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS).
Determine the subjects' acceptance of sloughing and/or other side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors did not know what toothpaste subjects used.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;
- •Have a dental appointment scheduled during study duration for professional cleaning;
- •Is pregnant, nursing, or planning to become pregnant within the study duration;
- •History of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (e.g., cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves and prosthetic implants);
- •History of using a prescription antimicrobial mouth rinse during the past 3 months;
- •Currently taking medications which may alter gingival appearance/bleeding;
- •Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health;
- •Participation in any other clinical study within the last 30 days;
- •Resides in the same household with a subject already enrolled in the study;
- •Known history of sensitivity to oral hygiene products;
- •Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes);
- •History of diabetes;
- •Have removable partial/full dentures;
- •Have orthodontic appliances;
- •Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study;
- •Have known sloughing within the last 3 weeks;
- •Have dry mouth;
- •Have widespread caries or chronic neglect;
- •Have gross pathological changes of oral soft tissues;
- •Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss);
- •Unsuitable for enrollment in this study based on the professional opinion of the dental examiner based on the oral exam or other reasons not specified in the protocol
研究组 & 干预措施
Comparator: No SLS Toothpaste
3M Oral Rinse in combination with no SLS toothpaste (A)
干预措施: Anti-plaque (Device)
Comparator: No SLS Toothpaste
3M Oral Rinse in combination with no SLS toothpaste (A)
干预措施: No SLS toothpaste (Drug)
Comparator: Medium SLS Toothpaste
3M Oral Rinse in combination with medium SLS toothpaste (B)
干预措施: Medium SLS toothpaste (Drug)
Comparator: Medium SLS Toothpaste
3M Oral Rinse in combination with medium SLS toothpaste (B)
干预措施: Anti-plaque (Device)
Comparator: High SLS Toothpaste
3M Oral Rinse in combination with high SLS toothpaste (C)
干预措施: High SLS toothpaste (Drug)
Comparator: High SLS Toothpaste
3M Oral Rinse in combination with high SLS toothpaste (C)
干预措施: Anti-plaque (Device)
结局指标
主要结局
Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
时间窗: End of treatment (3 weeks)
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
次要结局
- The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores(Mid-Treatment (10 days))
- The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.(End of Treatment (3 weeks))