Efficacy of Malic Acid Spray in Treatment of Xerostomia in Type II Diabetic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The unstimulated salivary flow rate
研究概览
简要总结
Background: xerostomia is a subjective sensation of dry mouth resulting from quantitative and /or qualitative changes of saliva. Patients receiving drugs like antihypertensives and antidepressants or patients receiving chemotherapy or radiotherapy for treatment of head and neck cancers may suffer from xerostomia. It also can be experienced in patients with systemic diseases like diabetes mellitus, systemic lupus erythematosus, sjogren's syndrome and rheumatoid arthritis. Malic acid spray with concentration of 1% has grabbed the attention over the last few years as an effective treatment for xerostomia.
Study objective: To evaluate the effect of 1% malic acid spray in treatment of xerostomia in type 2 diabetic patients.
详细描述
This randomized controlled clinical trial included 52 patients with type 2 diabetes mellitus suffering from xerostomia, divided equally into two groups. Group-I was managed by topical spray containing 1% malic. Group- II was managed by a placebo spray. Both groups received the treatment for 2 weeks. Dry mouth questionnaire scores (DMQ) and unstimulated salivary flow rate was collected before and after treatment.
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
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with type 2 diabetes mellitus suffering from xerostomia.
- •Patients aged between 35 and 50 years old.
- •Glycated hemoglobin less than 7% (28) .
- •Duration of diabetes mellitus not less than 4 years and not more than 8 years.
排除标准
- •Patients receiving any drugs that cause hyposalivation like anti-hypertensive drugs.
- •Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus) (8).
- •Patients receiving chemo-therapy and radio-therapy.
- •Mouth breathers.
研究组 & 干预措施
malic acid group
patients will receive a topical spray containing 1% malic acid
干预措施: malic acid (Drug)
结局指标
主要结局
The unstimulated salivary flow rate
时间窗: 4 weeks
The unstimulated salivary flow rate will be obtained by the spit method every 30s for 15 minutes. Saliva will be collected in graduated tubes. Measurements will be expressed as milliliter per minute. Participants will be asked to refrain from eating, drinking and brushing their teeth at least 2 hours before saliva collection - Hypo-salivation if the unstimulated salivary flow rate 0.1- 0.2 ml/min or less
次要结局
- scoring of severity of xerostomia(4 weeks)
研究者
Hams Hamed Abdelrahman
Assistant lecturer
Alexandria University