Stability of Maxillary Anterior Teeth After Two Years of Retention in Adolescents - A Randomized Controlled Trial Comparing Two Bonded and a Vacuum-formed Retainer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Changes in CPD
研究概览
简要总结
After orthodontic treatment 3 different retention devices will be compared.Thirty patients in each group; Group 1) Bonded retainer 13-23, Group 2)Bonded retainer 12-22 and Group 3) Vacuum-formed retainer covering all erupted teeth in the maxilla. Retention capacity between these three devices will be compared after 2 years of retention by measuring Contact Point displacements (CPD) between 6 anterior teeth and sum of 5 anterior CPDs called Little´s Irregularity Index (LII).
详细描述
Studies have shown that esthetics, no doubt, is the major motivating factor for orthodontic treatment both in adults and adolescents.Orthodontic relapses are usually described as changes toward the pretreatment status. These changes occur very fast if the teeth are not kept in their new position. That is the reason why, after orthodontic treatment, the result must be stabilized by some kind of retention device to prevent relapse. However, after this first period of remodeling of periodontal structures, comes the later period of changes.
Relapse in aesthetic zone (Anterior teeth), is the major reason why patients are dissatisfied with the results and seek for retreatment. There is a gap in our knowledge which kind of retention device is more effective to stabilize achieved alignment after orthodontic treatment.
This randomized clinical trial, tries to answer to that question. The investigators shall compare three different retention devices and measure changes after 2 years when retention devices have been in place and later compare the long-term results when the retainers have been removed after 2 years of retention (future study 5 years ptstretention).
Randomization Three months before the estimated removal of the fixed appliances, the patients will be invited to take part in the trial. After gaining informed consent from the patient and their custodians, the patients are randomly allocated to one of the three retention groups as follow: A) bonded retainer 13-23, B) bonded retainer 12-22 and C) removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization process is prepared by an independent person and carried out by three staff members not involved in the trial. The randomization uses blocks of 30. The randomization notes is delivered in a sealed opaque envelope each. Every new participant picked an envelope and reveal the group assignment by opening the envelope. Recruitment is ongoing until the total number of participants meet the estimated sample size.
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
- Single (Outcomes Assessor)
盲法说明
All study casts will be scanned without name just with a number and assessor do not know which group they belong to.
入排标准
- 年龄范围
- 11 Years 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young children age between 11 to 19 years old undergone orthodontic treatment.
排除标准
- •Syndrome patients
- •Skeletal discrepancy
- •missing maxillary anterior teeth
结局指标
主要结局
Changes in CPD
时间窗: 2 years after retention device in place
Changes in single contact point discrepancy of five maxillary anterior teeth
Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth
时间窗: 2 years after retention device in place
Sum of five single contact points of maxillary anterior teeth
次要结局
- Intercanine distance(2 years after retention device in place)
- Intermolar distance(2 years after retention device in place)
