Department of Oral Surgery, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology. No. 639 Zhi Zao Ju Road, Huang Pu District, Shanghai, 200011, China.
Department of Oral Surgery, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology. No. 639 Zhi Zao Ju Road, Huang Pu District, Shanghai, 200011, China.
J Craniomaxillofac Surg. 2019 Apr;47(4):602-606. doi: 10.1016/j.jcms.2019.01.045. Epub 2019 Feb 4.
To evaluate the preliminary clinical outcomes on the Chinese standard temporomandibular joint (TMJ) prostheses.
Patients who underwent Zimmer Biomet and Chinese standard prostheses by one surgeon between January 1st 2016 and June 30th 2017 were included in the study. Maximum incisal opening (MIO), pain, diet, and joint function were measured; CT scans were taken before and after the operation and during at least a 12-months follow-up for evaluation.
Thirty-five patients including 12 with Chinese standard prostheses and 23 with Biomet stock prostheses participated in the study. After an average of 14.3 months follow-up, both types of prostheses could significantly improve MIO, diet, and joint function, and relieve pain (p < 0.05). There were no significant differences in diet, pain level and joint function either before or after the operation between the two types of prostheses, whereas after the operation, the MIO with Chinese standard prostheses was significantly larger than with the Biomet stock prostheses (p < 0.05). However, there was no significant difference before operation (p > 0.05). A computed tomography (CT) scan showed that no prostheses dislocated or broke, no screws loosened, and ectopic bone formation appeared around the alloplastic condyle.
Chinese standard TMJ prostheses are effective and stable in clinical application. They can significantly improve mouth opening, diet, and joint function and relieve pain.
评估中国标准颞下颌关节（TMJ）假体的初步临床效果。
本研究纳入了 2016 年 1 月 1 日至 2017 年 6 月 30 日期间由同一位外科医生采用 Zimmer Biomet 和中国标准假体进行治疗的患者。测量最大开口度（MIO）、疼痛、饮食和关节功能；在术前、术后以及至少 12 个月的随访期间进行 CT 扫描以进行评估。
本研究共纳入 35 例患者，其中 12 例采用中国标准假体，23 例采用 Biomet 库存假体。平均随访 14.3 个月后，两种类型的假体均能显著改善 MIO、饮食和关节功能，并缓解疼痛（p<0.05）。两种假体在术前或术后的饮食、疼痛程度和关节功能方面均无显著差异，而术后中国标准假体的 MIO 明显大于 Biomet 库存假体（p<0.05）。然而，术前两者之间无显著差异（p>0.05）。CT 扫描显示无假体脱位或断裂，无螺钉松动，异体质骨形成出现在假体髁突周围。
中国标准 TMJ 假体在临床应用中是有效且稳定的。它们能显著改善开口度、饮食和关节功能，并缓解疼痛。
