NCT06750068尚未招募不适用
Clinical Evaluation of Digitally Fabricated 3D-printed Band and Loop Space Maintainers Versus Conventional Band and Loop Space Maintainer : a Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Survival rate
研究概览
简要总结
This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.
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
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lower first permanent molar in active state of eruption
- •Patient and parent showing cooperation and compliance.
- •Medically free children.
- •According to space analysis available space is less than or equal to needed space
- •Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss)
- •Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines.
排除标准
- •Children with previous allergies to stainless steel.
- •There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
- •The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)
结局指标
主要结局
Survival rate
时间窗: 1 year
Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers
次要结局
- Gingival health of the abutment(0,6,12 months)
- Plaque accumulation on the abutment tooth(0,6,12 months)
- Patients' satisfaction about the impression technique(Immediately after the im- pression/scanning)
研究者
Aya Alaa Abdelaziz Elsayed
Assistant lecturer
Cairo University
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