Clinical Evaluation of Different Designs of Fixed Space Maintainer. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Median survival rate
研究概览
简要总结
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B&L), Group II: Single-sided band and loop (Ss B&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T&L). children were recalled at 3, 6, 9, 12,15-month.
详细描述
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B&L), Group II: Single-sided band and loop (Ss B&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T&L). children were recalled at 3, 6, 9, 12,15-month. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Sample size: The total sample size was calculated using Sampsize application with anticipated success on treatment with conventional band and loop 86% , anticipated response on treatment with direct bonded wire 33% 12, at 80% power, and significant level 0.05.
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
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and their parents showed cooperation and compliance.
- •Extraction of the first primary molar was not exceeding three months.
- •Angle's class 1 occlusion with normal deciduous molar relation
- •Child not complaining from any systemic disease.
- •The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
- •Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
- •No restorative application on the buccal surfaces of abutment teeth, otherwise extra-coronal complete coverage, as stainless-steel crown, was applied only in banded groups.
- •Radiographically, presence of permanent successor.
- •Absence of any pathological evidence on the eruption track of the permanent tooth.
- •Ability to attend follow-up appointments as required.
排除标准
- •Child complaining from any systemic disease.
- •Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
- •Extraction of the first primary molar was exceeding three months.
- •The extraction space resulted from more than one missing deciduous molar
- •Radiographically, absence of permanent successor.
结局指标
主要结局
Median survival rate
时间窗: 15 months
Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test
次要结局
未报告次要终点