Chewing Pattern Changes Before and After Space Maintainer Placement in Children
Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：afra savas
- 电话号码：90 5343279274
- 邮箱：aafranursavas@gmail.com
学习地点
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Maltepe
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Istanbul、Maltepe、土耳其（türkiye）
- Marmara University
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接触：
- savas
- 电话号码：90 5343279274
- 邮箱：aafranursavas@gmail.com
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria: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. -
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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A unilateral fixed band-and-loop space maintainer will be placed as part of routine clinical care following premature loss of a primary molar.
The appliance will be cemented to the abutment tooth with glass ionomer cement, and occlusion will be checked after placement.
The space maintainer is not assigned for research purposes; it is clinically indicated before study enrollment.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Masticatory Performance
大体时间：Baseline and 4 weeks after space maintainer placement
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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.
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Baseline and 4 weeks after space maintainer placement
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Change in Chewing Pattern
大体时间：Baseline and 4 weeks after space maintainer placement
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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.
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Baseline and 4 weeks after space maintainer placement
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- chewing.p
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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