Systematic review of outcomes reported in trials of facial trauma

This study aimed to identify and collate outcomes reported in trials of facial trauma. Searches for randomised controlled trials on facial trauma containing 50 patients or more were conducted on Cochrane CENTRAL, Embase and Ovid MEDLINE on 9 October 2025. Additional studies were identified through review of the reference lists of relevant systematic reviews and included trials, as well as through text searches of Google Scholar. A manual search of clinicaltrials.gov and the International Standard Randomised Controlled Trial Number (ISRCTN) registry was also completed in line with Cochrane guidelines on 20 November 2025. A total of 3,695 studies were screened following PRISMA guidelines, with 131 articles included in the final analysis. Two reviewers (KC and NB) independently performed data extraction, and the outcomes reported were recorded verbatim and mapped on to the World Health Organization International Classification of Functioning, Disability and Health (WHO ICF) framework. A total of 151 distinct outcomes were identified, with a median of four outcomes per trial. Mapping to the WHO ICF yielded 102 outcome domains. Eighty-two studies involved the mandible only, 39 involved the midface only, nine involved the mandible and midface, and one involved the midface and frontal bone. In mandibular fracture trials, immunological system functions that would capture infections (56%), structure of the mouth (53%) and pain (41%), were most frequently reported. In midfacial fracture trials, pain was the most common domain (37%), followed by immunological system functions (31%). Seven patient-reported outcome measures (PROMs) were identified across 10 trials, most commonly the General Oral Health Assessment Index. Outcome reporting in facial trauma trials is highly heterogeneous, spanning all domains of the WHO ICF framework, with limited and inconsistent use of PROMs. Most available PROMs were not designed specifically for facial trauma, and no single instrument was used consistently across the studies. This lack of standardisation limits comparability between trials and hinders meaningful evidence synthesis. These findings support the need for the development of a consensus-based core outcome set for facial trauma to improve consistency, relevance, and quality of outcome reporting in future research.