DRKS00017393已完成未知
Investigation of a medical device (ipalat® Hydro Med Lutschpastille) on saliva production andon changes in salivary surface tension in healthy subjects with dry mouth - P363
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Healthy male, female and diverse subjects at least 18 years of age
- •-Written informed consent
- •-Willingness to actively participate in the study
- •-Dry mouth (xerostomia 10.3.3) at least 40 mm VAS (total length 100 mm, ranging from not
- •dry to extremely dry)
- •-Willingness to avoid heavy sweating (e.g. sauna, sport, swimming) one day prior to the
- •measurements
- •-Willingness not to eat spicy or salty foods, including garlic and onions one day prior to the
- •measurements
- •-Willingness not to consume alcohol extensively in the evening prior to the measurements
- •-Willingness to avoid excitement (e.g. exams, tests) in the morning prior to the measurements
- •-Willingness to avoid food with a saliva reducing effect (e.g. alcohol, caffeine-containing
- •beverages, sugar-containing beverages with carbonic acid) 4 hours prior to the measurements
- •-Willingness to avoid food with a saliva stimulating effect (e.g. citrus fruits, chewing gums, chamomile, sage, marshmallow root) 4 hours prior to the measurements
- •-Willingness to avoid food requiring extensive chewing (e.g. carrots, apples, celery) 4 hours
- •prior to the measurements
- •-Willingness not to smoke 4 hours prior to the measurements
- •-Willingness not to eat or drink (except water) within 90 minutes prior to the measurements
- •-Willingness not to change the prosthesis or artificial dentition throughout the course of the
- •-Willingness to inform the study site in case of changes in therapies especially regarding the
- •medication which caused xerostomia
- •-Negative urine pregnancy test (in female subjects of child bearing potential).
排除标准
- •-Poor general health condition -Pregnancy or lactation -Drug addicts, alcoholics, AIDS or infectious hepatitis if known to the subjects -Conditions which exclude a participation or might influence the test reaction/evaluation -Active disease at test area -Subjects suffering from diseases of the salivary glands -Subjects suffering of dental or other problems within the oral cavity -Subjects with chewing or swallowing Problems -Systemic therapy with immuno-suppressive drugs and/or antihistamines within the last 7 days (long-term therapy for at least 3 months is allowed) -Xerostomia developed recently (less than 3 months) or due to short term drug intake -Therapy with antibiotics within the last 2 weeks and/or ongoing -Ongoing radiation or chemotherapy throughout the course of the study -Surgery in test area within the last 4 weeks -Fever or gastrointestinal infection within the last 7 days prior to the start of the study -regular intake (=4/d) of chewing gum or pastilles within 2 weeks prior study start -Prosthesis or artificial dentition within the last 4 weeks prior the start of the study and throughout the course of the study -Smoking within the last 4 hours before the scheduled visits -Intake of any food or beverages (except water) within the 90 minutes prior to the
- •measurements -Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies
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