Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- Changes in Tooth Position
研究概览
简要总结
The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period.
A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.
The null hypotheses are:
- that there is no difference in retention capacity between Essix retainer and cuspid-to-cuspid retainer
- that there is no difference in patients' perception between Essix retainer and cuspid-to-cuspid retainer
- that there is no difference in retention capacity for Essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment
详细描述
The study is conducted at the Orthodontic Clinic, Gävle, Sweden and consists of 104 patients. All patients are treated with fixed appliances in the upper and lower jaw (standard .022 straight wire), both with and without extractions. The patients are randomized into two groups with 52 patients in each group (Group A: cuspid-to-cuspid retainer, Group B: Essix retainer).
Dental cast are obtained at the debond appointment (T1) and at the follow-up controls after six months (T2), 18 months (T3) and 60 months (T4) for both groups.
At the visit two weeks in retention and at the follow-up visits after 6, 18 and 60 months the patients assess questionnaires in order to evaluate their experience of retention with the retention device.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients treated with fixed appliances in both the maxilla and the mandible
排除标准
- •Rapid Maxillary Expansion (RME) for patients with severe transversal malocclusion
- •Treatment with segmented appliances
- •Patients with craniofacial anomalies and patients requiring orthognatic surgery
- •Patients with missing mandibular incisor
结局指标
主要结局
Changes in Tooth Position
时间窗: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)
Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)
次要结局
- Patients' Perception(T4 (5 years follow up))