ISRCTN58887461已完成未知
ong-term effectiveness of a novel intra-oral electro-stimulator for the treatment of dry mouth in patients with Sjogren's syndrome: a feasibility study
niversity College London Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 30 人开始时间: 2012年7月30日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Be at least 18 years of age
- •2. Have clinical symptoms of xerostomia (dry mouth) due to primary SS syndrome diagnosed on the basis of 2001 EUUSA classification criteria
- •3. Degree of dry mouth symptoms: a minimum degree of dryness of 50mm (=50mm) on a 100mm VAS scale (0= no dryness; 100 = maximum dryness)
- •4. NO systemic sialogogue therapy (e.g. pilocarpine) for the duration of the study
- •5. Female patients of child bearing potential must have a negative pregnancy test within twenty-four hours of enrolment
- •6. To understand and consent in writing to the procedure
- •7. To agree to undergo all the examinations and clinical evaluations of the study
- •8. To have evidence of residual salivary gland function, by demonstrating an increase in salivary flow on appropriate stimulation e.g. citric acid stimulation or chewing paraffin wax)
- •9. To have unstimulated whole salivary flow higher than 0 ml/15min (unstimulated salivary flow as measured via sialometry for 15 minutes)
- •10. Male and female particioants
排除标准
- •1. Severe systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASAIII and ASA IV)
- •2. Known allergy to materials similar to those used in the investigational product
- •3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids
- •4. Complete lower edentulous status (i.e. possess no lower teeth)
- •5. To have oral anatomical or disease-related characteristics that preclude the insertion of the device (e.g. mandibular torus, severe trismus)
- •6. To be unable or unwilling to cooperate with study procedures
- •7. To have evidence of no residual salivary gland function (via citric acid stimulation or chewing paraffin wax test)
- •8. To have an unstimulated whole salivary flow = 0 ml/15min (Absence of unstimulated salivary flow as measured via sialometry for 15 minutes)
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