Preliminary clinical study of Chinese standard alloplastic temporomandibular joint prosthesis.

PURPOSE: To evaluate the preliminary clinical outcomes on the Chinese standard temporomandibular joint (TMJ) prostheses. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: Chinese standard TMJ prostheses are effective and stable in clinical application. They can significantly improve mouth opening, diet, and joint function and relieve pain.