Comprehensive analysis of clinical research profiles and study characteristics of oral potentially malignant disorders: an observational study.

OBJECTIVE

The study aims to present an observational study of clinical trials on Oral Potentially Malignant Disorders (OPMDs) and corresponding publications.

STUDY DESIGN AND SETTING

We searched the OPMDs-related clinical studies registered in the ClinicalTrials.gov database before March 1, 2024. Subsequently, we investigated the publication status of primary completed studies using PubMed and Google Scholar.

RESULTS

A total of 185 studies were identified for analysis, including 141 interventional studies and 44 observational studies. The most commonly studied disease type was oral lichen planus (OLP), accounting for 113 studies (61.1 %). Interventional studies on OPMDs were predominantly early-phased, blind, randomized, parallel and single-center. The primary purpose of these studies was treatment (106, 75.2 %). Among the treatments, herbal medicine (21, 19.8 %), photodynamic therapy (17, 16.0 %), and glucocorticoids (14, 13.2 %) were of greatest interest. In addition, 58 (63.0 %) of the primarily completed interventional studies were published, with a median time to publication of 33.6 months. Published interventional studies including OLP patients and factorial designs had shorter time to publication. However, these studies were less frequently published in high-impact journals and most primary results were positive.

CONCLUSIONS

Clinical trials on OPMDs predominantly focused on OLP and herbal medicine. The quality of studies is unsatisfactory and publication rate is suboptimal. Improvements are needed in ClinicalTrials.gov registration standards, high-quality study design and more stringent publishing requirements.