Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,008
- 主要终点
- Assessing the presence of peri-implantitis
研究概览
简要总结
Evidence for the undeniable role of microscrews in anchorage control, as well as their other advantages, such as ease of insertion and removal techniques, have led to their routine use in orthodontics. Treatment with microscrews, despite its obvious advantages, is associated with the risk of complications, the etiology of which is multifactorial. Identifying (and subsequently controlling) as many of them as possible through research constitutes an ongoing challenge for scientists. This pursuit defined the purpose of the present study: to determine whether a type of TISAD insertion technique - self-drilling or self-tapping - as well as the patient's sex and maxillary quadrant constitute predisposing factors for the occurrence of certain complications.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.
排除标准
- •Inadequate oral hygiene
- •Chronic diseases (e.g. diabetes)
- •Tooth loss
研究组 & 干预措施
Insertion with self-drilling technique
Each patient received two microimplants both using self- drilling method. In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
干预措施: Orthodontic miniscrew insertion using self-drilling method (Procedure)
Insertion with self-tapping technique
Each patient received two microimplants both using self-tapping method. In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
干预措施: Orthodontic miniscrew insertion using self-tapping method (Procedure)
结局指标
主要结局
Assessing the presence of peri-implantitis
时间窗: The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
Assessing the presence of pain lasting longer than 48 hours after implantation.
时间窗: 2 weeks after implantation
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
Assessing the presence of root perforation
时间窗: Immediately after implantation
Root perforation was diagnosed in CBCT performed after the procedure.
Assesing the presence of microimplant fracture
时间窗: During implantation
Microimplant fracture was diagnosed during implantation, reported by the clinician.
Assessing the stability of miniscrews
时间窗: During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
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