Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Retainer failure at 6-month and 2-year follow-ups
研究概览
简要总结
The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. In particular, the CAD/CAM device Keeppy patented by the company Leone SpA (Via Ponte a Quaracchi 50, Sesto Fiorentino, Florence) will be compared with the standard retainer made from a steel braided wire (Ortho FlexTech, Reliance Orthodontic Products Inc., 1540 West Thorndale Ave, Itasca, Illinois, USA).
This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.
The aim of this study is to evaluate whether the CAD/CAM retainer results in fewer failures (fractures or detachments) over a period of 6 months and 2 years compared to the standard retainer. In addition, the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer. Other objectives consist of the patient's assessment of pain, difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector.
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
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
- •Patients whose parents will sign the informed consent
排除标准
- •Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
- •Patients with metal allergies.
研究组 & 干预措施
CAD/CAM mandibular fixed retainer
干预措施: CAD/CAM mandibular fixed retainer (Device)
Conventional mandibular fixed retainer
干预措施: Conventional mandibular fixed retainer (Device)
结局指标
主要结局
Retainer failure at 6-month and 2-year follow-ups
时间窗: At 6 months and at 2 years
The primary endpoint is retainer failures at 6-month and 2-year follow-ups. Failure is defined as any complication requiring a retainer repair, in particular total or partial detachment and total or partial fracture.
次要结局
- Stability of the alignment of the lower anterior teeth(At 6 months and at 2 years)
- Pain reported by patients(At baseline, at one month, at 6 months and at 2 years)
- Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.(At baseline, at 6 months and at 2 years)
- Difficulty in speaking reported by patients(At baseline, at one month, at 6 months and at 2 years)
- Aesthetic satisfaction reported by patients(At baseline, at one month, at 6 months and at 2 years)