The Effectiveness of Polyether-Ether-Ketone (PEEK) as a Fixed Retainer Compared to Multistranded Stainless Steel Wires: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Stability of lower anterior teeth
研究概览
简要总结
A randomized clinical trial is set out to compare the effectiveness of two types of fixed retainer (multistranded stainless steel and PEEK types) in maintaining the stability of lower anterior teeth with less failure rate.
详细描述
It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: multistranded stainless steel fixed retainer will be used while, and group two PEEK fixed retainer will be used. An intra-oral scan, intra-oral swap and periodontal indices will be taken before starting the treatment (T0), after one month (T1), after 3 months (T2), and after 6 months (T3). Patient perception concerning the fixed retainer will be taken for the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 32 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 17-32 years.
- •Patients with a score of 0-0.5 on Little's irregularity index in the lower arch.
- •Patients treated with the pre-adjusted orthodontic appliance (both Extraction and non-extraction cases).
- •Patients who have healthy periodontal condition
排除标准
- •Patients treated with rapid maxillary expansion or surgically assisted rapid maxillary expansion.
- •Patients with a cleft lip / and or palate.
- •Patients with a deep overbite and traumatic parafunctional habits such as bruxism and clenching.
- •Patients with carious, restored, fractured, or missing lower anterior teeth.
- •Patients with medical health problems that may influence gingival health like uncontrolled type II diabetic patient, patients with hormonal disturbances or systemic drug administration that effect on oral health.
结局指标
主要结局
Stability of lower anterior teeth
时间窗: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
The effectiveness of PEEK retainers as compared to a dead-soft multi-stranded stainless-steel wire in maintaining alignment of the lower anterior teeth in terms of Little's irregularity index.
次要结局
- Periodontal health status(T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month)
- Patient satisfaction(At T1 after one month and T3 after 6 month)
- Biohostability(T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month)
- Failure rate(T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month)
研究者
Esraa Salman Jasim
Assist.Prof.
University of Baghdad