Effectiveness of Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients: A Single-blind Randomized Clinical Trial and a CONSORT-compliant Article
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- oral health status (OHS)
研究概览
简要总结
Objectives: To evaluate the effectiveness of green tea mouthwash on the oral health status (OHS) in oral cancer patients undergoing anticancer treatment.
Materials and methods: This was a prospective, single-blind, randomized, controlled trial. Patients were randomly assigned to 2 groups: mouthwash with green tea (intervention) group or tap water (control) group. The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily, and the control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily. The primary outcome was OHS, which was evaluated according to the Oral Assessment Guide and measured at seven time points by the same researcher. Time 0 (T0) corresponded to baseline, and Time 1-6 (T1-T6) corresponded to monthly outpatient follow-ups until six months.
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
- None
盲法说明
Because of the nature of the intervention, only the data analyst was blinded to the meaning of the group assignment code.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were > 20 years
- •newly diagnosed with oral cancer by a physician
- •just received oral surgery and follow-up with or without chemotherapy or radiation therapy.
排除标准
- •patients with mental illness
- •an acute and a severe illness status
- •no teeth in the whole mouth
- •the ability of mouth opening less than 1 cm.
结局指标
主要结局
oral health status (OHS)
时间窗: Time 6(T6) corresponded to the 6th month after recruitment.
Patients' oral health status (OHS) was assessed according to the Oral Assessment Guide (OAG) by the same researcher. The OAG consists of eight items: voice, swallow, lips, tongue, saliva, mucous membranes, gingiva and teeth or dentures. Each item is rated by a grading of 1 (normal) to 3 (severe). Sum scores between 8-24 points and a higher score indicate poorer OHS.
次要结局
未报告次要终点