Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Masticatory Performance
研究概览
简要总结
This prospective observational study aims to evaluate changes in chewing patterns and chewing performance in children before and after placement of a unilateral fixed band-and-loop space maintainer. Children aged 6-10 years who require a space maintainer as part of routine clinical care will be evaluated before appliance placement and again four weeks after placement. Chewing pattern will be assessed by observing the preferred chewing side during standardized chewing trials, and chewing performance will be evaluated using a two-color chewing gum test scored with the Orophys Subjective Assessment Scale. No additional invasive procedure will be performed for research purposes; the space maintainer treatment will be provided as part of routine clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-10 years. Premature loss or extraction of a primary molar in the maxilla or mandible with a clinical indication for a unilateral fixed band-and-loop space maintainer.
- •The abutment tooth for the space maintainer is vital and either sound or appropriately restored.
- •Complete dentition on the contralateral side of the arch to allow reliable assessment of chewing function.
- •No systemic condition affecting chewing function. Written informed consent provided by a parent or legal guardian; children aged 9 years and older also provide written assent.
排除标准
- •Severe developmental delay, severe behavioral problems, or neuromuscular disorders that may directly affect chewing function, muscle activity, or treatment cooperation.
- •Temporomandibular joint disorder. Current orthodontic treatment. Anterior or posterior crossbite, open bite, or other skeletal/dental malocclusions that may affect chewing function.
- •Additional missing teeth in the contralateral arch, including hypodontia. Craniofacial anomalies, including cleft lip/palate syndromes. Systemic conditions requiring special medical precautions or antibiotic prophylaxis during routine dental treatment. -
研究组 & 干预措施
Children Receiving a Unilateral Band-and-Loop Space Maintainer
Children aged 6-10 years with premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer. Chewing pattern and chewing performance will be assessed before space maintainer placement and again four weeks after placement.
干预措施: Band-and-Loop Space Maintainer (Device)
结局指标
主要结局
Change in Masticatory Performance
时间窗: Baseline and 4 weeks after space maintainer placement
Change in masticatory performance from before space maintainer placement to 4 weeks after placement, assessed using a two-color chewing gum test. After 20 chewing cycles, color mixing will be scored using the Orophys Subjective Assessment Scale from SA1 to SA5, with higher scores indicating more complete color mixing and better masticatory performance.
Change in Chewing Pattern
时间窗: Baseline and 4 weeks after space maintainer placement
Change in chewing pattern from before space maintainer placement to 4 weeks after placement. The dominant chewing side (right/left) will be observed during seven standardized chewing trials. Children using the same side in at least four of seven trials will be classified as unilateral chewers; those showing side alternation will be classified as bilateral chewers.
次要结局
未报告次要终点