Abstract:

Objective　To evaluate and compare the clinical effects of the self-designed and Zimmer Biomet standard temporomandibular joint （TMJ） prostheses. Methods　Thirty-five patients who underwent either self-designed standard prostheses（12 cases） or Zimmer Biomet standard prostheses（23 cases） by one surgeon between January 2016 and June 2017 were included in the study. Maximum incisal opening （MIO），pain，limitation at eating，mandibular function and quality of life were compared before and after operation during at least 12 months of follow-up，and CT scan was taken for evaluation. Results　After an average of 14.3 months of follow-up，both types of prostheses could significantly improve MIO，limitation at eating，mandibular function，quality of life ，and  pain （P＜0.05）. There were no significant differences in limitation at eating，pain level，quality of life or mandibular function before operation between the two groups. After operation，MIO in self-designed prostheses group ［（39.18±6.06）mm］ was significantly larger than that of Zimmer Biomet prostheses group ［（32.39±5.35）mm］ （P＜0.05），although there was no significant difference in other aspects （P＞0.05）. CT scan showed that there were no prostheses dislocation，broken prostheses，or ectopic bone formation. Conclusion　Self-designed standard TMJ prostheses are effective and stable in clinical application. It can significantly improve mouth opening，limitation at eating，mandibular function and quality of life，and it can relieve pain.

Key words: artificial temporomandibular joint, Biomet standard prosthesis, self-designed standard prosthesis

摘要：

目的　对比研究自主研发标准型人工颞下颌关节假体与Biomet标准型人工颞下颌关节假体的临床应用效果。方法　选择2016年1月至2017年6月在上海交通大学医学院附属第九人民医院口腔外科进行人工颞下颌关节置换的患者35例，均由同一位主刀医生完成手术安装自主研发标准型人工颞下颌关节假体（自主研发组，12例）或Biomet标准型人工颞下颌关节假体（Biomet组，23例），并有1年以上临床和影像学随访资料。对两组患者手术前后最大张口度、疼痛评分、饮食受限评分、下颌运动功能评分及生活质量评分进行比较，并进行CT影像学评价。结果　经过术后平均14.3个月的随访发现，两组患者的最大张口度、疼痛评分、饮食受限评分、下颌运动功能评分及生活质量评分均较治疗前显著改善，差异有统计学意义（P＜0.05）。 尽管两组患者在术前上述指标比较差异均无统计学意义，但术后自主研发组患者最大张口度［（39.18 ± 6.06）mm］显著大于Biomet组患者［（32.39 ± 5.35）mm］（P＜0.05），其他指标两组间差异均无统计学意义。CT检查显示，两组患者均无假体移位、断裂和异位成骨等。结论　自主研发标准型人工颞下颌关节假体临床应用效果稳定，能显著改善患者的最大张口度、饮食受限、下颌运动功能和生活质量，缓解疼痛。

关键词: 人工颞下颌关节, Biomet标准型假体, 自主研发标准型假体