Performance and Tolerability of a New Medical Device Coating Gel for the Temporary Relief of Teething Symptoms: a Randomized, Open Label, Parallel-group, Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- changes in gingival swelling
研究概览
简要总结
Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
详细描述
Due to the potential toxicity that can result from the use of topical anesthetics to relieve the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid (HA) have been marketed in Europe. In particular, Bioplax Limited is developing several high molecular weight HA 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 HA 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 HA medical device evidenced, at the end of treatment period, a statistically significant reduction of pain, swelling, gingival rush, hyper-salivation and redness, 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
- Other
- 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 3 and 36 months.
- •Teething diagnosed by the presence of at least 3 of the following clinical symptoms:
- •hyper-salivation
- •abnormal teeth depth.
- •At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
- •Infants and parents who are in a general position to follow all study requirements.
- •Informed consent form signed by parents or legal representative.
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 oral Lidocaine, other topical oral anesthetic products 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 other anesthetics (except Dentinox®-Gel N, for subjects allocated to group II of treatment).
- •Subjects with known family history of allergic or adverse reactions to drugs or substances.
- •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.
研究组 & 干预措施
HA BPX V3.3
A HMWHA gel available in a formulation specificaly designed for use in infants
干预措施: HA BPX V3.3 (Device)
Dentinox-Gel N
Gold standard for teething symptoms
干预措施: Dentinox-Gel N (Other)
结局指标
主要结局
changes in gingival swelling
时间窗: 3 days
Face, Legs, Activity, Cry and Consolability Pain Assesment Scale
次要结局
- changes in crying(7 days)