收稿日期: 2022-02-18
录用日期: 2022-05-08
网络出版日期: 2022-08-19
基金资助
上海申康医院发展中心临床三年行动计划(SHDC2020CR3060B);黄浦区产业扶持基金(XK2020013)
Clinical evaluation of Chinese embeded temporomandibular joint anchoring nail
Received date: 2022-02-18
Accepted date: 2022-05-08
Online published: 2022-08-19
Supported by
Three Years Clinical Research Plan of Shanghai Shenkang Hospital Development Center(SHDC2020CR3060B);Huangpu District Industrial Support Fund(XK2020013)
目的·介绍一种采用全埋入式设计的国产新型颞下颌关节锚固钉,并通过临床试验进行效果评价。方法·选取2018年6月—2018年11月于上海交通大学医学院附属第九人民医院口腔外科进行颞下颌关节盘复位固定术的不可复性关节盘前移位患者43例,对于单侧手术患者采用国产全埋入式新型锚固钉复位关节盘,对于双侧手术患者采用右侧新型锚固钉、左侧传统锚固钉复位。分别在术前及术后1个月、术后6个月、术后1年进行临床及磁共振成像(magnetic resonance imaging,MRI)检查评估。临床评估指标包括最大张口度、颞下颌关节疼痛视觉模拟评分;MRI结果评价采用“三圆法”,聚焦于关节盘位置、关节盘长度和髁突高度。采用重复测量方差分析对术前术后患者开口度、疼痛评分、关节盘长度、髁突高度进行统计分析。结果·共31例患者(53侧关节)完成全部随访。国产全埋入式新型锚固钉和传统锚固钉的手术成功率分别为90.3%和90.9%。术后1年,患者下颌运动功能明显改善,张口度由术前的(34.65±8.63)mm提高至(42.84±7.46)mm,差异有统计学意义(P=0.000);患者疼痛明显缓解,疼痛评分由术前的(2.94±1.13)分降低至(0.39±0.55)分,差异有统计学意义(P=0.000)。术后MRI结果显示关节盘长度增加;术后6个月髁突高度与术后1个月髁突高度比较,差异无统计学意义(P>0.05),术后1年髁突高度较术后1个月髁突高度平均增加1.54 mm(P=0.002)。应用新型锚固钉的患者31侧关节均无异物感,而应用传统锚固钉的22侧关节中,7例患者表示在该侧耳屏前能触摸到突起,其中2例患者出现明显异物感。结论·国产全埋入式新型锚固钉与传统锚固钉的手术成功率相近,且能显著减少术后异物感。颞下颌关节盘复位固定术有助于改善关节功能、缓解疼痛,新骨形成可在术后1年通过MRI检出。
毛懿 , 陈旭卓 , 王学宏 , 谢昕儒 , 徐伟峰 , 黄慧 , 张善勇 . 国产全埋入式颞下颌关节锚固钉的临床应用评价[J]. 上海交通大学学报(医学版), 2022 , 42(6) : 723 -728 . DOI: 10.3969/j.issn.1674-8115.2022.06.005
·To introduce and evaluate a Chinese embedded temporomandibular joint (TMJ) anchoring nail in a clinical trial.
·From June 2018 to November 2018, 43 patients with anterior disc displacement without reduction were selected from the Department of Oral Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. TMJ disc reposition and fixation was performed to them all. For unilateral patients, a Chinese embedded nail was used to reduce the articular disc. For bilateral patients, a Chinese embedded anchoring nail was used on the right side and a traditional anchoring nail was used on the left side. Clinical and magnetic resonance imaging (MRI) examination were performed before surgery, 1 month after surgery, 6 months after surgery and 1 year after surgery. Clinical evaluation indexes included maximum interincisal opening (MIO) and TMJ pain score. The disc position, disc length and condylar height were measured by MRI, by using three-circle method. Repetitive measnre analysis of variance was used for statistical analysis of preoperative and postoperative MIO, visual analog scale (VAS) score for TMJ pain, disc length and condyle height.
·Thirty-one patients with fifty-three joints finished all follow-up periods. The success rates of Chinese embedded anchoring nail and traditional anchoring nail were 90.3% and 90.9%, respectively. One year after surgery, the patients' jaw motion improved significantly. The MIO increased from (34.65±8.63) mm before surgery to (42.84±7.46) mm 1 year after surgery (P=0.000). The pain was significantly alleviated, and the VAS score for TMJ pain decreased from (2.94±1.13) before surgery to (0.39±0.55) 1 year after surgery (P=0.000). Postoperative MRI examination result showed increased disc length. The condyle height did not change significantly 6 months after surgery (P>0.05), but it increased by an average of 1.54 mm 1 year after surgery (P=0.002). None of the 31 joints with the Chinese embeded anchorage nail had foreign body sensation, while of the 22 joints with the traditional anchorage nail, 7 patients could feel the protrusion in front of the tragus, and 2 of them had obvious foreign body sensation.
·Improved Chinese embedded TMJ anchoring nail has similar success rate and less foreign body sensation than traditional anchoring nail. TMJ disc repositioning and fixation is beneficial to improve joint function and relieve pain. New bone can be detected 1 year after surgery.
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