A Randomized, Open, Parallel-group Multicenter Study of Efficacy and Tolerability of a New Medical Device in Gel Formulation (Hyaluronic Acid 0.54%) Versus Calgel® for the Topical Treatment of Teething in Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Teething pain
研究概览
简要总结
This is a randomized, open label, parallel-groups, multicenter study. The study will be conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey flavour gel medical device class IIa.
详细描述
Due to the potentially serious toxicity that can result from the use of topical anesthetics to relieving the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid have been marketed in Europe. In particular, Ricerfarma is developing several high molecular weight Hyaluronic Acid medical devices characterized by the absence of preservatives, alcohol and dyes; therefore, the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue. In previous clinical trials with these high molecular weight Hyaluronic Acid medical devices it was noted a periodontal tissue/fluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms (i.e. soreness and swelling of gums, crying, sleeplessness) related to the teething in infants. These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight Hyaluronic Acid medical device evidenced, at the end of treatment period, for pain, swelling, gingival rush, hyper-salivation and redness a statistically significant reduction from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infants aged between 6 and 36 months.
- •Teething diagnosed by the presence of at least 3 of the following clinical symptoms:
- •pain, swelling, gingival rush, hyper-salivation, redness, abnormal teeth depth.
- •At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
- •Informed consent form signed by parents or legal representative.
- •Infants and parents who are in a general position to follow all study requirements
排除标准
- •Infants in hospitalization and/or immobilization and/or confinement to bed.
- •Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems
- •Use of topical Lidocaine and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
- •Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
- •Concomitant use during the period of study of NSAIDs and/or any anesthetics (obviously Calgel® is allowed in patients randomized in group B, only)
- •Subjects with known history of allergic or adverse reactions to avian proteins or to HA and to any ingredient of the Medical Device and/or of the comparator on study.
- •Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject.
- •Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.
- •Infants already treated under this protocol.
研究组 & 干预措施
Hyaluronic Acid 0.54%
Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day.
干预措施: Hyaluronic Acid 0.54% (Device)
Calgel®
Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours.
干预措施: Calgel® (Drug)
结局指标
主要结局
Teething pain
时间窗: day 0, 3 and 7
scored according to intensity with the following Verbal Rating Scale: Absent = 0, Moderate = 1, Intense = 2
次要结局
- swelling(day 0, 3 and 7)
- day pain(day 0, 3 and 7)
- gingival rush(day 0, 3 and 7)
- hyper-salivation(day 0, 3 and 7)
- redness(day 0, 3 and 7)