Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Oral mucositis changes
研究概览
简要总结
The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.
详细描述
A pilot study showed that patients with chemotherapy-induced oral mucositis experienced accelerated healing of their oral mucositis by brushing with Oral Defense Toothpaste.
In this study, participants experiencing up to grade 2 chemotherapy-induced oral mucositis will be split into two arms. The first arm (test arm) will receive Oral Defense Toothpaste and be required to brush three times per day, for 8 days. The second arm (control arm) will receive Crest Toothpaste and be required to brush three times per day, for 8 days. Patients in the control arm will be provided Magic Mouth Rinse, if needed. Healing of oral mucositis lesions will be evaluated at days 1 and 8. Quality of life assessment (determination of pain/loss of oral function) will be determined using a daily questionnaire.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 receiving chemotherapy
- •Mucositis lesions not exceeding grade 2
排除标准
- •Patients receiving high load chemotherapy
- •Patients receiving radiation therapy
- •Patients receiving oral antivirals, oral antifungals or oral antibacterials
- •Patients experiencing oral candidiasis
研究组 & 干预措施
Oral Defense Toothpaste
The experimental group will brush with Oral Defense Toothpaste three times per day during the study
干预措施: Oral Defense Toothpaste (Drug)
Crest Toothpaste/Magic Mouth Rinse
The placebo group will brush with Crest Toothpaste three times per day during the study. Participants in the placebo comparator group who require additional management of their oral mucositis pain will be provided Magic Mouth Rinse.
干预措施: Magic Mouth Rinse (Drug)
Crest Toothpaste/Magic Mouth Rinse
The placebo group will brush with Crest Toothpaste three times per day during the study. Participants in the placebo comparator group who require additional management of their oral mucositis pain will be provided Magic Mouth Rinse.
干预措施: Crest Toothpaste (Drug)
结局指标
主要结局
Oral mucositis changes
时间窗: Day 1 and 8 of the study
The primary measure is the healing of chemotherapy induced oral mucositis lesions which are evaluated at days 1 and 8 of the study. The clinical investigators will identify patients who qualify for the study and this will mark day 1 of the study. At days 1 and 8 of the study, the clinical investigators will evaluate the oral cavity of each study participant and document changes in the oral mucositis of the participants.
次要结局
- Quality of life changes(8 days)