NCT03232255已完成不适用
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in dentine hypersensitivity
研究概览
简要总结
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one hypersensitive tooth in everyday life after PAV 1 in-office visit
- •At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit
- •At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at study entry
- •Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root
- •For subjects entering the study at stage PAR-control: good healing of the periodontal surgery site, cause of pain must not be the result of the periodontal surgery
- •Age ≥ 18 years and ≤ 75 years
- •Willing and able to attend the on-study visits
- •Willing and able to understand and to follow the study procedures and instructions
- •Good oral hygiene throughout the study
- •Written informed consent before participation in the study
- •Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control)
排除标准
- •Hypersensitivity only due to sweets
- •Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc lactate
- •Professional desensitizing therapy during the previous 3 months; GLUMA (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months
- •Chronic systemic anti-inflammatory and analgesic medications
- •Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.)
- •Teeth or supporting structures with any other painful pathology or defect
- •Subject with poor health conditions
- •Concurrent participation in another clinical trial
- •Pregnant or lactating women
研究组 & 干预措施
Treatment Group
Experimental
干预措施: Mouthrinse (IQP-OLP-101) (Other)
结局指标
主要结局
Change in dentine hypersensitivity
时间窗: 28 days
Assessed by subjects using VAS
次要结局
未报告次要终点
研究者
研究点 (2)
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