The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in quality of life
研究概览
简要总结
The purpose of this study was to examine the efficacy of N-acetyl cysteine in the treatment of burning mouth syndrome. A control group of patients with burning mouth syndrome will receive a placebo. The effect of the therapy will be monitored with the help of the visual-analogue scale (VAS) and the oral health-related quality of life questionnaire (OHIP-14).
详细描述
The research will include patients who come to the Department of Oral Medicine at the Faculty of Dentistry in Zagreb, and who have been diagnosed with burning mouth syndrome. It is planned to gather a total of 60 patients, 30 patients in the treatment group and 30 in the placebo group.
The purpose and protocol of the research will be explained to the patients. If they are willing to participate, they will sign an informed consent previously approved by the Ethics Committee of the Faculty of Dentistry. They will fill in the OHIP-14 questionnaire and the VAS scale, grading from 0-10, where 0 indicates a condition without symptoms, and 10 the strongest possible intensity of symptoms. They will be randomly assigned to a therapeutic or placebo group and will receive the medicine in an unmarked box. The drug will be taken for two months at a dose of 1200 mg per day. After that, they will come for a check-up and re-complete OHIP-14 and record the intensity of symptoms according to the VAS scale.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of burning mouth syndrome
排除标准
- •pregnancy, breastfeeding or pregnancy planning
- •anamnestic data about active gastric or duodenal ulcer
- •decreased levels of serum iron or B vitamins
研究组 & 干预措施
Control group
female patients with primary burning mouth syndrome
干预措施: placebo (Other)
Study group
female patients with primary burning mouth syndrome
干预措施: N-acetyl cysteine (Dietary Supplement)
结局指标
主要结局
Change in quality of life
时间窗: up to 8 weeks
measured with OHIP-14 (Oral Health-Related Quality of Life questionnaire); the answer options with their respective values were as follows: 0 = never, 1 = rarely, 2 = sometimes, 3 = repeatedly, 4 = always, with a maximum score of 56. The higher the score, the worse quality of life.
次要结局
- Change in subjective symptoms of burning mouth(up to 8 weeks)
研究者
Božana Lončar Brzak
Associate Professor
University of Zagreb