[Characteristics analysis of oral clinical trials registered in Chinese Clinical Trial Registry].

Objective: To investigate the project characteristics of oral clinical trials registered in Chinese Clinical Trial Registry (ChiCTR), and to provide reference for medical institutions to improve the quality of oral clinical trials and formulate management systems. Methods: The ChiCTR database was retrieved to collect all the oral-related clinical trials from the time of database establishment to July 25, 2021. Those clinical trials were analyzed statistically in respect of name of registered project, registration time, registration status, regional distribution of research institutions, approval status by ethics committee, sample size, source of funds, involved disease, research type and design, randomization method, and whether blind method was adopted. Results: A total of 778 oral clinical trials, which studied mainly in the oral and maxillofacial diseases, periodontal tissue diseases, oral implant diseases, oral mucosal diseases, and oral prosthetic diseases, were retrieved in the database. Beijing, Sichuan, Shanghai, Guangdong and Hubei were major regions where oral clinical trials were carried out, accounting for 69.68% (772/1 108) of the total. The top four funding sources were hospital finance [24.93% (186/746)], local government finance [22.39% (167/746)], self-financing [17.69% (132/746)], and national finance [12.47% (93/746)]. For the types of researches, 520 interventional studies and 244 observational studies were identified (accounting for 66.84% and 31.36%, respectively). The research designs were dominated by ways of randomized control (381, 48.97%), of which 240 (62.99%) trials were with missing or unspecified blinding methods. Conclusions: Oral clinical trials are increasing year by year, but they are regionally imbalanced, and still need to be further improved in registration information and research design. Administrative departments should pay more attention to strengthen the publicity and education on the registration and publication mechanism of clinical trials, and enhance researchers' cognitions in clinical trials registration and clinical trials design.

FOXP3 T regulatory cells in lesions of oral lichen planus correlated with disease activity.

OBJECTIVE: The aim of this study was to determine the correlation between the number of FOXP3(+) T cell in lesions and the disease activity of patients with oral lichen planus (OLP). MATERIALS AND METHODS: The expression of FOXP3 was investigated using immunohistochemical staining and real-time RT-PCR in 23 OLP lesions and 12 controls. Changes of FOXP3(+) Treg in peripheral blood from three patients' pre and post-treatment were assessed using flow cytometry. RESULTS: Few FOXP3(+) cells were detected in controls, but an increased number of FOXP3(+) cells were observed in lesions (n = 20, 40.99 +/- 24.68 cells per high-power field - hpf). Furthermore, the frequency of FOXP3(+) Treg in reticular OLP (n = 7, 63.6 +/- 23.2 cells per hpf) was significantly higher than that in erythematous/erosive OLP (n = 13, 28.8 +/- 16.8 cells per hpf, P = 0.001). In addition, negative correlation was found between the number of FOXP3(+) Treg and disease activity (correlation oefficient = -0.557, P = 0.013). The proportion of FOXP3(+) Treg showed remarkable increase in peripheral blood from patients after treatment (1.39 +/- 0.71%vs 4.91 +/- 1.59%). CONCLUSIONS: These data indicated that FOXP3(+) Treg were involved in the pathogenesis of OLP and correlated with disease's subtype and activity.