Evidence-based Selection of Orthodontic Miniscrews, Increasing Their Success Rate in the Mandibular Buccal Shelf: A Randomized, Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Assessing the presence of pain lasting longer than 48 hours after implantation.
研究概览
简要总结
Stability of the orthodontic miniscrews placed in the mandible is still considered to bare higher risk of failure compared to other intraoral locations. The aim of our study was to determine the influence of the miniscrew size on their long-term stability, occurrence of oral mucosa inflammation and pain lasting over 48 hours after implantation.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy Caucasians
- •mild Class III maloclussion that required an absolute anchorage for en-masse distalization in the mandible
- •hypodivergent or normal angle between the maxillary and mandibular planes
- •excellent oral hygiene
排除标准
- •Hyperdivergent angle between the maxillary and mandibular planes
- •unfavorable anatomical conditions - e.g. presence of a strong frenulum potentially irritating the miniscrew head during chewing and/or facial movement
结局指标
主要结局
Assessing the presence of pain lasting longer than 48 hours after implantation.
时间窗: two weeks
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
Assessing the presence of peri-implantitis
时间窗: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
Assessing the stability of miniscrews
时间窗: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
The mobility of the miniscrews was checked clinically with cotton tweezers at each visit. Miniscrews that could not sustain orthodontic force and required replacement because of mobility were considered failures.
次要结局
未报告次要终点
研究者
Michał Sarul
Associate Professor
Wroclaw Medical University