Retrospective Analysis of the Effects of a Gum Gel Intended to Treat Signs and Symptoms of Teething in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Salivation
研究概览
简要总结
Teething discomfort is a widespread disorder affecting a very high percentage of infants. The use of hyaluronic acid gels has been shown in the last 20 years to be an effective tool, generally devoid of side effects, in reducing oral mucosal inflammation in adults. Its effectiveness in infants is affected by the strength of hyaluronic acid retention over the oral mucosa. This is in turn affected by formulation and may vary between different products due to the different ingredients used. In this study, the results collected by monitoring the paediatric experience regarding a newly developed HA-based medical device, intended to counteract teething discomfort in infants, will be reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Teething discomfort
- •Being healthy (except for teething discomfort)
排除标准
- •Being placed on one of the following therapies in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotics, antifungal and hormone therapy
结局指标
主要结局
Salivation
时间窗: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
General well-being
时间窗: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Inappetence
时间窗: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Unexplained cry
时间窗: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Gum redness
时间窗: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Irritability
时间窗: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
Fever
时间窗: 1 month (1 check per week)
Number of days with fever
Sleep disturbance
时间窗: 1 month (1 check per week)
5-level Likert scale completed by the paediatrician
次要结局
未报告次要终点
研究者
Davide Sisti
PhD
University of Urbino "Carlo Bo"