NCT05087147Unknown不适用
Clinical Evaluation of Bonded Versus Banded Space Maintainers in Children With Prematurely Lost First Primary Molars: A Randomized Controlled Clinical Trial
Omar Sherif Ahmed Abo El Abbas0 个研究点目标入组 36 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 主要终点
- appliance failure
研究概览
简要总结
Comparing bonded space maintainers to banded space maintainers
详细描述
Comparing bonded space maintainers to banded ones regarding clinical success in maintaining the space for the prematurely lost primary molar and radiographic space loss in both banded and bonded space maintainers. Finally, patient satisfaction regarding both treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Statisticians
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient and parent showing cooperation and compliance. Medically free children. Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
- •Having all first permanent molars erupted and in Class I molar relation. According to space analysis available space is less than or equal to needed space.
- •Having all their mandibular incisors erupted. With deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.
排除标准
- •Children with any parafunctional habits. Children with previous allergies to stainless steel. Crowned abutment teeth. Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
研究组 & 干预措施
Banded space maintainer
Active Comparator
Band and loop space maintainer
干预措施: Banded space maintainer (Device)
Bonded space maintainer
Experimental
Wire bonded with composite to abutment teeth
干预措施: 0.7 mm stainless steel orthodontic wire (Device)
结局指标
主要结局
appliance failure
时间窗: up to 12 months
Patient reported
次要结局
- Radiographic space loss(up to 12 months)
研究者
Omar Sherif Ahmed Abo El Abbas
Assistant Lecturer
Cairo University
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