Artificial Saliva in Diabetes Type II: a Randomized Registry Cross Over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- xerostomia
研究概览
简要总结
In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.
详细描述
In diabetes Type II the xerostomia is a quite frequent symptom. The trial was conducted at a single center. Designed and implementing UNI EN ISO 14155:2012, STROBE statement Version 4 and was in conformity with the guidelines of the Declaration of Helsinki.
The type of study was a randomized, cross over clinical trial to compare two treatments (artificial saliva spray (aldiamed(R) mouth spray) AS vs. (Tonimer(R) Throat Spray) TT .
Twenty one subjects that were part of the epidemiological screening for asymptomatic vascular diseases conducted in the Irwin Lab3 of Spoltore (PE / Italy) The degree of xerostomia for the admission had to be at least > 2 according to a semi-quantal scale (ranging from 0 to 6) and patients already under treatment for xerostomia or with xerostomia score < 2, suffering from obesity, cancer, drug addiction or alcoholism were excluded.
The patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The study consisted of a preliminary selection during screening, the measurement of xerostomia and random allocation, first treatment period, wash out period and finally the second treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The two types of pump-spray had a different bottle design but the bottles were blank with no identification
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffering xerostomia
- •degree of xerostomia at least > 2 according to a semiquantal scare ranging from 0 to 6
- •diabetes Type II > one year, with stabilized oral hypoglycemic therapy from at least 6 months.
- •concomitant chronic diseases pertaining to dyslipidemia, cardiovascular and/or gastrointestinal diseases, and anxiety/depression were accepted provided under adequate therapy since at least 6 months.
排除标准
- •under treatment for xerostomia or with xerostomia score < 2
- •suffering from obesity (BMI > 30 kg/m2),
- •cancer of any type
- •drug addiction and alcoholism
研究组 & 干预措施
artificial saliva spray (AS)
The randomized part of the participants who started first with the artificial saliva spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days.
After wash out phase they take for three days the marine water throat spray taking it three times a day for a three days treatment.
干预措施: artificial saliva spray (AS) (Device)
artificial saliva spray (AS)
The randomized part of the participants who started first with the artificial saliva spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days.
After wash out phase they take for three days the marine water throat spray taking it three times a day for a three days treatment.
干预措施: maritime throat spray (TT) (Other)
maritime throat spray (TT)
The randomized part of the participants who started first with the marine water throat spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days.
After wash out phase they take for three days the artificial saliva spray taking it three times a day for a three days treatment.
干预措施: maritime throat spray (TT) (Other)
maritime throat spray (TT)
The randomized part of the participants who started first with the marine water throat spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days.
After wash out phase they take for three days the artificial saliva spray taking it three times a day for a three days treatment.
干预措施: artificial saliva spray (AS) (Device)
结局指标
主要结局
xerostomia
时间窗: first day before treatment; change to third day after treatment (day 1+3; 7+9)
xerostomia was measured according to a semi-quantal visual scale (or VAS; visual analogue scale) ranging from 0 to 6 with intervals of 1 point
次要结局
- stimulated salivary flow(first day before treatment; change to third day after treatment (day 1+3; 7+9))
- antioxidant capacity of saliva (SAT test)(first day before treatment; changes to third day after treatment (day 1+3; 7+9))
- patients preference for treatment AS or TT(third day after finalization of the treatment period (day 3; 9))