Clinical Study to Evaluate the Efectiveness and Tolerability of a New Gel for Xerostomia
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- OHIP 14
研究概览
简要总结
At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures:
- General measures ; review and control of drugs,hydration and dietary advice:
The main recommendations are found in the following scheme. 2. Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion.
Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline 3. Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.
详细描述
Randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes
- •Over 18 years.
- •Adequate cultural level and understanding of the clinical study.
- •Agree to voluntarily participate in the study and give their informed consent in writing
- •Present xerostomia of more than three months of evolution / sialometry less than 0.2ml / 5 min.
- •Exclusion criteria
- •The presence of at least one of the following criteria will be grounds for exclusion from the clinical trial:
- •Presence of health problems that may compromise adherence to the study protocol.
- •Pregnant or breastfeeding women.
- •Present hypersensitivity to any component of the product under study.
排除标准
- 未提供
研究组 & 干预措施
GROUP EXPERIMENTAL
Gel xerostomia Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
干预措施: gel xerostomia (Drug)
CONTROL GROUP
Gel placebo Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
干预措施: gel placebo (Other)
结局指标
主要结局
OHIP 14
时间窗: 1moth
Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases
Test Thonsom xerostomy
时间窗: 1moth
Xerostomia Inventory. the higher the outcome, quality of life decreases
Sialometry
时间窗: 1moth
Drenaje
次要结局
未报告次要终点
研究者
Pia Lopez Jornet
UNIVERSIDAD DE MURCIA
Universidad de Murcia