A Prospective Clinical Trial evaluating a CAD-CAM Fabricated Jig for Precision bonding of fixed Retainers assessing the Breakage Rate and Alignment Stability: A 6- Month Follow up Syudy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Breakage rate of fixed retainers
研究概览
简要总结
This prospective clinical trial aims to evaluate the effectiveness of a novel CAD-CAM fabricated jig for precision bonding of fixed retainers. The study will compare the jig assisted bonding technique with conventional direct bonding in terms of retainer breakage rate, alignment stability, periodontal health and arch width changes over a 6 month follow up period. A total of two groups will be assessed with clinical measurements recorded at baseline, 1 month, 3 months and 6 months follow up to determine efficacy and safety. The goal is to improve the precision, efficiency and long term success of fixed retainer placement in post orthodontic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 14.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Completed fixed appliance orthodontic treatment with satisfactory correction of malocclusion
- •Anterior teeth of adequate size and shape for bonded retainer placement
- •No missing anterior teeth in upper or lower arch
- •In good systemic health
- •willing and able to comply with the trial protocol
- •Provided written informed consent.
排除标准
- •Presence of cleft palate or severe facial deformities
- •Nickel Allergy
- •Gross or uncontrolled caries
- •Need for prosthodontic treatment in the upper or lower arch post treatment
- •Lower incisor extraction cases.
结局指标
主要结局
Breakage rate of fixed retainers
时间窗: Baseline, 1 month, 3 months, 6 months
次要结局
- Gingival index(Baseline, 1 month, 3 months, 6 months)
- Plaque Index(Baseline, 1 month, 3 months, 6 months)
- Irregularity index(Baseline, 1 month, 3 months, 6 months)
- Arch width changes(Baseline, 1 month, 3 months, 6 months)
研究者
MUSKAN CHANDUKA
Saveetha Dental College