A Single-center, 3-arm, Parallel-group Randomized Controlled Trial to Evaluate the Effectiveness of Three Orthodontic Retention Schemes in Preventing Post-treatment Mandibular Arch Changes and Gingival Recession in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Little's Irregularity Index in the mandible (mm)
研究概览
简要总结
The present study aims to assess the effectiveness of three different retention schemes used to maintain tooth position after orthodontic treatment with fixed orthodontic appliances (stability) and to evaluate possible association between retention scheme and gingival recessions on the lingual surfaces of the lower anterior teeth seen for up to 5 years post-treatment. Moreover the possible association between primary relapse tendency and long term occlusal stability will be evaluated.
详细描述
This is a randomized, controlled, single-center, equivalence trial with three parallel groups and an allocation ratio of 1:1:1, that aims to investigate the effectiveness of 3 orthodontic retention schemes on post-treatment mandibular arch stability and gingival recession.
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both sexes
- •Age between 10 and 16 years
- •At the finishing stage of orthodontic treatment, programmed for debonding
- •Class I to Class II molar relationship before the beginning of orthodontic treatment
- •Non-extraction treatment plan with fixed straight-wire appliances
- •Space deficiencies and irregularity of no more than 6mm in the maxillary/ mandibular arch (Irregularity Index)
排除标准
- •No missing teeth, impacted teeth or other dental anomalies
- •No congenital anomalies/ syndromes
结局指标
主要结局
Changes in Little's Irregularity Index in the mandible (mm)
时间窗: 1 year in retention, 2 years in retention, 5 years in retention
Changes in Intercanine width in the mandible (mm)
时间窗: 1 year in retention, 2 years in retention, 5 years in retention
Changes in Interpremolar width in the mandible (mm)
时间窗: 1 year in retention, 2 years in retention, 5 years in retention
Changes in Arch length in the mandible (mm)
时间窗: 1 year in retention, 2 years in retention, 5 years in retention
Changes in Intermolar width in the mandible (mm)
时间窗: 1 year in retention, 2 years in retention, 5 years in retention
次要结局
- Changes in Intercanine width in the maxilla (mm)(1 year in retention, 2 years in retention, 5 years in retention)
- Changes in Interpremolar width in the maxilla (mm)(1 year in retention, 2 years in retention, 5 years in retention)
- Changes in Overbite and Overjet (mm)(1 year in retention, 2 years in retention, 5 years in retention)
- Leveling or torque related problems of the lower anterior teeth(1 year in retention, 2 years in retention, 5 years in retention)
- Changes in Intermolar width in the maxilla (mm)(1 year in retention, 2 years in retention, 5 years in retention)
- Changes in Gingival Recessions on the lingual surfaces of the six lower anterior teeth(1 year in retention, 2 years in retention, 5 years in retention)
- Changes in Arch length in the maxilla (mm)(1 year in retention, 2 years in retention, 5 years in retention)
- Accidental bond failures of fixed retainers or breakages of removable ones(1 year in retention, 2 years in retention, 5 years in retention)
研究者
Iosif Sifakakis
Associate Prof., Department of Orthodontics, School of Dentistry
University of Athens