Effects of an External Oral Irrigation Device on Patients With Dry Mouth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Oral Health Related Quality of Life (OHRQoL)
研究概览
简要总结
The purpose of this research study is to test the effectiveness of treating dry mouth through water rehydration using this extra oral water pump/irrigation device.
详细描述
Dry mouth causes difficulty with chewing, swallowing, speech, and increases the risk dental cavities. It also can cause discomfort in the mouth, and a loss of general quality of life. The oral irrigation device supplies a small amount of water to participant's mouth through a small tube that is placed in the corner of the mouth throughout the time participants wear it.
In this study, participants will be asked to:
- Visit the dental school clinic two (2) times for study visits.
- Wear the oral irrigation device as directed by the investigator.
- Keep notes at home.
- Answer survey questions during both dental visits about dry mouth symptoms.
- Give permission for the researchers to collect information about medications or health conditions that contribute to dry mouth from participant's medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who report xerostomia (dry mouth) and are diagnosed after testing with hypofunctioning salivary glands
排除标准
- •Patient who after testing do not exhibit salivary hypofunction
- •Patient with limited English proficiency
结局指标
主要结局
Change in Oral Health Related Quality of Life (OHRQoL)
时间窗: Baseline to 4 - 6 weeks
OHRQoL will be assess using the Oral Health Impact Profile (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items on the scale. Higher OHIP-14 scores indicate worse and lower scores indicate better OHRQol
Clinical Changes in Unstimulated Saliva Flow
时间窗: Baseline to 4 - 6 weeks
Data on routine unstimulated saliva testing as performed as standard of care for patients suspected to have reduced salivary flow will be compared before and after use of the device.
Change in Oral Dryness
时间窗: Baseline to 4 - 6 weeks
Clinical Oral Dryness Score (CODS) conducted during the clinical exam assesses ten key features of dry mouth and allocates one point for each feature. The total score ranges from 0 to 10 with higher scores indicating more severe dry mouth.
Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI)
时间窗: Baseline to 4 - 6 weeks
OHRQoL-XI will be assessed using the Xerostomia Inventory (XI), an 11-item summated rating scale which combines the responses to 11 individual items into a single continuous scale score which represents the severity of chronic xerostomia. Scores range from 11 to 55 with higher scores represent more severe symptoms.
Clinical Changes in Stimulated Saliva Flow
时间窗: Baseline to 4 - 6 weeks
Data on routine stimulated saliva testing as performed as standard of care for patients suspected to have reduced salivary flow will be compared before and after use of the device.
次要结局
未报告次要终点