Al-Hilaly Ahmed Ali, Alhuwaizi Akram Faisal
Babylon Health Directorate, Iraqi Ministry of Health, Babylon, Iraq; Department of Orthodontic, College of Dentistry, University of Baghdad, Baghdad, Iraq.
Department of Orthodontic, College of Dentistry, University of Baghdad, Baghdad, Iraq.
J World Fed Orthod. 2025 Apr;14(2):67-75. doi: 10.1016/j.ejwf.2024.09.006. Epub 2024 Nov 8.
Using miniscrews to control anchorage made the application of force for various orthodontic treatment approaches easier and increased their effectiveness. Some problems may occur during the use of miniscrews, such as peri‑implant mucositis, mobility, postoperative pain, and failure. This study compared the success rate of miniscrews coated with chlorhexidine hexametaphosphate antimicrobial nanoparticles with that of uncoated miniscrews.
In a double-blind randomized controlled clinical trial using a split-mouth design, 80 miniscrews were inserted symmetrically into 40 individuals between the maxillary second premolar and first molar. Random allocation software was used to distribute the coated and uncoated miniscrews. The patients were monitored monthly, for a duration of 4 months. The main measure of interest was the success rate of miniscrews, which was assessed throughout follow-up periods of up to 4 months. The secondary objective was the assessment of the mobility of the miniscrews, peri‑implant health, and pain perception. A Wilcoxon signed-rank test and Kaplan-Meier survival analysis were applied to analyze the data.
Main outcome: After the 4-month follow-up, the success rates of the miniscrews for coated and uncoated samples were 81.3% and 84.4%, respectively, which was a statistically insignificant difference.
Mobility and peri‑implant health were not statistically different between the coated and uncoated miniscrew groups. Pain intensity was rated higher on the first day, then decreased gradually, diminishing completely on the sixth and seventh day. However, the pain perception between the coated and uncoated miniscrews did not differ statistically.
Chlorhexidine-hexametaphosphate nanoparticles did not increase the success rate and stability, nor did they enhance peri‑implant health or affect pain perception during the short observation period.
This trial was registered at ClinicalTrials.gov; ID: NCT06124235.
使用微螺钉控制支抗使各种正畸治疗方法的施力更加容易，并提高了其有效性。在使用微螺钉的过程中可能会出现一些问题，如种植体周围黏膜炎、松动、术后疼痛和失败。本研究比较了涂有六偏磷酸氯己定抗菌纳米颗粒的微螺钉与未涂层微螺钉的成功率。
在一项采用双盲随机对照临床试验的分口设计中，将80枚微螺钉对称植入40名个体的上颌第二前磨牙和第一磨牙之间。使用随机分配软件分发涂层和未涂层的微螺钉。对患者进行为期4个月的每月监测。主要关注指标是微螺钉的成功率，在长达4个月的随访期内进行评估。次要目标是评估微螺钉的松动度、种植体周围健康状况和疼痛感知。应用Wilcoxon符号秩检验和Kaplan-Meier生存分析来分析数据。
主要结果：4个月随访后，涂层和未涂层样本的微螺钉成功率分别为81.3%和84.4%，差异无统计学意义。
涂层和未涂层微螺钉组之间的松动度和种植体周围健康状况在统计学上无差异。疼痛强度在第一天评分较高，然后逐渐降低，在第六天和第七天完全消失。然而，涂层和未涂层微螺钉之间的疼痛感知在统计学上没有差异。
在短观察期内，六偏磷酸氯己定纳米颗粒没有提高成功率和稳定性，也没有改善种植体周围健康状况或影响疼痛感知。
本试验在ClinicalTrials.gov注册；标识符：NCT06124235。
