NCT01174329Unknown2 期
Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation
Universidad Autonoma de Nuevo Leon1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2010年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- self-reported xerostomia
研究概览
简要总结
The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range between 18 and 75 years of age
- •Clinical symptoms of xerostomia
- •Difference in whole salivary flow between resting and stimulating conditions
- •Patient ASA type I to III
- •Absence of at least one mandibular third molar inferior, but at least partially dentated in the mandible
排除标准
- •Patients with antimicrobial treatments in the three previous months
- •Intake of bisphosphonates
- •Limitation of mandibular opening
- •Interoclusal distance smaller than 10 millimetres
- •Lack of adequate bone availability for implant placement
结局指标
主要结局
self-reported xerostomia
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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