NCT03513003招募中不适用
The Use of a Pacifier to Correct Malocclusions in Young Children
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Posterior cross bite
研究概览
简要总结
The aim of the study is to investigate the effect of a pacifier (102 Medical Pacifier, Curaprox, Switzerland) on malocclusions like posterior crossbite, anterior open bite, larger overjet and tongue dysfunction in young children.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who are sucking the pacifier and / or baby bottle for the last 6 months in use.
- •Manifesting posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite.
- •- Manifesting anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.
排除标准
- •Children who are thumb- or fingersucking (or sucking other objects)
- •syndromic or cleft patients
- •patients with history of cranio-facial trauma, history of temporomandibular joint infection or musculo-skeletal asymmetry (e.g. scoliosis, torticollis)
- •patients with systematic diseases
- •patients currently under or after orthodontic Treatment
- •patients with ankylosed teeth (e.g. after dental trauma).
结局指标
主要结局
Posterior cross bite
时间窗: 1 year
presence of posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite.
Anterior open bite
时间窗: 1 year
presence of anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.
次要结局
- Facial movement(1 year)
- Lip competence(1 year)
- Facial morphology(1 year)
研究者
研究点 (2)
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