Speed of Premolar Extraction Space Closure: The Effect of Every Visit Replacement of Working Arch Wire - A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The amount of space closure per month
研究概览
简要总结
The aims of this trial were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro, and to assess its effect on the rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure.
详细描述
The aims were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro and to assess its effect on rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure and to compare the rate of teeth movement into fresh and old extraction sites.
Trial design: Randomized controlled clinical trial with a split-mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.
Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the upper arch two groups were identified; group 1 having the extraction space closed using the same working archwire throughout 3 visits after insertion, and group 2 with the working archwire changed monthly.
The working archwire in the upper arch was split into 2 halves in the midline and each one half was connected to the other by a wide joining hook. Patients were followed-up monthly for three months. At every follow up visit upper alginate impressions were taken and the working archwire in the upper arch was changed on one side only. Upper follow-up models were scanned using digital scanner and spaces were measured using digital software.
Three unstimulated saliva samples were collected from each patient; prior to commencement of treatment, when 0.019X0.25-inch SS archwire was reached and before space closure and one month after space closure.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The intervention was randomly allocated to either the right or left side using the permuted random block size of 2 with 1:1 allocation ratio. The random sequences for each intervention to either right or left sides was concealed in opaque envelopes and shuffled before the intervention to increase the unpredictability of the random allocation sequence. Each patient was asked to pick a sealed envelope to assign the intervention to either the right or left side. Allocation concealment was aimed to prevent selection bias and to protect the assignment sequence until allocation.
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 16 years
- •Proclined upper and lower incisors (Ui/max >115 o, Li/mand >99o)
- •Mild upper and lower arch crowding (<4mm) or no crowding
- •Need for upper and lower first premolars extraction
- •Skeletal I malocclusion (1<ANB <5)
- •Average lower facial height and maxillomandibular plane angle (22 o <MM<32 o)
- •Class I canine relationship
- •Good oral hygiene and healthy periodontium
排除标准
- •Poor oral hygiene
- •Diseases and medications that were likely to affect bone biology
- •Previous orthodontic treatment
- •Evidence of bone loss
- •Active periodontal disease
研究组 & 干预措施
Without changing working archwire
Extraction space closed using the same working archwire throughout 3 visits after insertion
干预措施: Space closure without changing working archwire monthly (Device)
With changing working archwire
The extraction space closed having the working archwire changed monthly.
干预措施: Space closure withchanging working archwire monthly (Device)
结局指标
主要结局
The amount of space closure per month
时间窗: 3 months
the width of upper extraction space in milimeters
次要结局
- ion concentration in saliva(through study completion, an average of 1 year)
- Frictional resistance(At the end of the study)
研究者
Elham Abu Alhaija
Professor
Jordan University of Science and Technology