Comparison of 3D Printed Metal Fixed Retainer Versus Conventional Fixed Bonded Retainer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- bond failure
研究概览
简要总结
Despite the growing diversity of materials used for mandibular fixed retainers, the evidence base remains inconclusive. In particular, conflicting findings have been reported regarding the bond failure of titanium retainers across different evaluation periods, including immediate and 12-month outcomes. Additionally, the emergence of 3D metal-printed retainers has not yet been matched by sufficient clinical evidence, with current data being limited and lacking long-term validation.
详细描述
In recent years, CAD/CAM technology and 3D printing have introduced new possibilities in orthodontic practice, with expanding applications across various treatment modalities. Additive manufacturing, commonly known as 3D printing, enables the fabrication of objects through the sequential layering of material to produce precise three-dimensional structures. While orthodontists are already familiar with 3D-printed appliances such as clear aligners, the application of these technologies in fixed retention is still evolving. Recent studies have reported the fabrication of customized lingual retainers using CAD/CAM techniques, including nickel-titanium-milled retainers and zirconia bars designed for use as bonded mandibular fixed retainers.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 13 years
- •Complete permanent dentition up to second molars
- •Completed Class I orthodontic treatment and requiring a mandibular fixed -bonded retainer
- •No sex predilection.
排除标准
- •Enamel defects that may compromise bonding (e.g., hypoplasia, fluorosis)
- •Poor oral hygiene
- •Active dental or periodontal pathology at the site of intervention
- •Lingual restorations on mandibular anterior teeth
- •Poor compliance or inability to attend follow-up visits
- •Psychological or medical conditions that may interfere with study participation
研究组 & 干预措施
Conventional fixed bonded retainer
干预措施: conventional fixed retainer (Device)
Bar 3d printed metal fixed retainer
干预措施: bar 3d printed metal fixed retainer (Device)
结局指标
主要结局
bond failure
时间窗: immediate (within 24 hours after bonding) and at 3, 6, 9, and 12 months
Bond failure will be assessed clinically by detecting any detachment of the retainer from the tooth surface (number of debonded teeth).
次要结局
- chairside time(Periprocedural (during retainer bonding procedure on Day 1))
- wire breakage(Every 3months for 12 months)
- plaque accumulation(Baseline (before retainer bonding) and at 3, 6, 9, and 12 months)
- posttreatment relapse(Baseline (before retainer bonding) and at 12 months)
研究者
Amany Ibrahim
assistant lecturer
Cairo University