A Prospective Study on the Therapeutic Outcomes of Mebo and Tantum Verde in Patients With Oral Mucositis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- WHO oral mucositis score
研究概览
简要总结
This study aimed to assess the efficacy of MEBO® in the treatment of already established oral mucositis. This is a randomized controlled clinical trial. The study included 36 patients with established oral mucositis, divided into two groups. Patients were randomly allocated to either receive topically applied MEBO® ointment or Benzydamine Hydrochloride (Tantum Verde) mouthwash three times a day for two weeks. We assessed the World Health Organization mucositis score (WHO), the Oral Mucositis Assessment Scale (OMAS), and the Patient-Reported Oral Mucositis Symptom (PROMS) score at baseline, and after one and two weeks.
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
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 who later on during radiotherapy developed oral mucositis with a severity of WHO score II or more and were over 18 years were then included in the study and allocated to one of the treatment groups .
排除标准
- •We excluded patients who were receiving any prophylactic agents and/or corticosteroids and those who would not sign the informed consent.
研究组 & 干预措施
MEBO
干预措施: MEBO Wound Ointment (MEBO) (Drug)
Tantum Verde
干预措施: Tantum Verde® mouthwash (Drug)
结局指标
主要结局
WHO oral mucositis score
时间窗: We assessed patients for the three outcomes at baseline, one week and at the end of the study period which is two weeks
The WHO oral mucositis score is an ordinal scale. The grades are as follows: Grade 0 is no mucositis, Grade 1 is soreness and/or erythema, Grade 2 involves ulcers and the ability to eat solids, Grade 3 indicates ulcers and the need for a liquid diet, and Grade 4 signifies ulcers with no possible oral alimentation
次要结局
未报告次要终点
研究者
Noha Adel Azab
Lecturer of Oral Medicine and Periodontology- Faculty of Dentistry
Cairo University