Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site- 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
- Amount of space closure
研究概览
简要总结
The aim was to compare the rate of teeth movement into fresh and old extraction sites.
详细描述
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 lower arch, two groups were also identified; group 1 having the first premolar extracted before the commencement of orthodontic treatment and group 2 having the first premolar extracted just before space closure when 0.019 x 0.025 inch SS archwire was reached. Patients were followed-up monthly for three months. At every follow-up visit lower alginate impressions were taken. Extraction spaces in the lower arch follow-up models were measured using digital caliper.
The rate of extraction space closure in the lower arch was assessed monthly.
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
After recruiting patients who met the inclusion criteria, 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
Healed extraction site
Old Extraction Space
干预措施: Space closure into old extraction space (Device)
unhealed extraction site
Recent Extraction space
干预措施: Space closure into recent extraction space (Device)
结局指标
主要结局
Amount of space closure
时间窗: 3 months
Width of extraction space will be measured in millimeters
次要结局
未报告次要终点
研究者
Elham Abu Alhaija
Professor
Jordan University of Science and Technology