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Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition

2026年8月10日更新者：Wroclaw Medical University

Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study

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.

研究概览

地位

完全的

条件

II 类咬合不正

干预/治疗

研究类型

介入性

注册 (实际的)

1008

阶段

不适用

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人

接受健康志愿者

是的

描述

Inclusion Criteria:

Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.

Exclusion Criteria:

Smoking,
Inadequate oral hygiene
Chronic diseases (e.g. diabetes)
Tooth loss

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	程序：Orthodontic miniscrew insertion using self-drilling method Patients received 2 miniscrews using self-drilling method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated complications were: peri-implantitis development ; the patient's report of pain lasting longer than 48 hours after miniscrew insertion. occurence of rooth perforation diagnosed in CBCT performed after procedure occurence of microimplant fracture during procedure microimplant failure recorded during subsequent follow-up visits.
实验性的：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.	程序：Orthodontic miniscrew insertion using self-tapping method Patients received 2 miniscrews using self-tapping method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated factors were: peri-implantitis development ; the patient's report of pain lasting longer than 48 hours after miniscrew -insertion. occurence of rooth perforation diagnosed in CBCT performed after procedure occurence of microimplant fracture during procedure microimplant failure recorded during subsequent follow-up visits.

参与者组/臂

干预/治疗

实验性的：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.

程序：Orthodontic miniscrew insertion using self-drilling method

Patients received 2 miniscrews using self-drilling method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated complications were:

peri-implantitis development ;
the patient's report of pain lasting longer than 48 hours after miniscrew insertion.
occurence of rooth perforation diagnosed in CBCT performed after procedure
occurence of microimplant fracture during procedure
microimplant failure recorded during subsequent follow-up visits.

实验性的：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.

程序：Orthodontic miniscrew insertion using self-tapping method

Patients received 2 miniscrews using self-tapping method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated factors were:

peri-implantitis development ;
the patient's report of pain lasting longer than 48 hours after miniscrew -insertion.
occurence of rooth perforation diagnosed in CBCT performed after procedure
occurence of microimplant fracture during procedure microimplant failure recorded during subsequent follow-up visits.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Assessing the presence of peri-implantitis 大体时间：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.	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).
Assessing the presence of pain lasting longer than 48 hours after implantation. 大体时间：2 weeks after implantation	Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.	2 weeks after implantation
Assessing the presence of root perforation 大体时间：Immediately after implantation	Root perforation was diagnosed in CBCT performed after the procedure.	Immediately after implantation
Assesing the presence of microimplant fracture 大体时间：During implantation	Microimplant fracture was diagnosed during implantation, reported by the clinician.	During implantation
Assessing the stability of miniscrews 大体时间：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.	During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Wroclaw Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年1月1日

初级完成 (实际的)

2024年3月31日

研究完成 (实际的)

2024年5月14日

研究注册日期

首次提交

2026年7月21日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2024年6月1日

Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition