A Systematic Review of Outcomes reported in Trials of Facial Trauma

Abstract Aims To identify and collate outcomes reported in trials of facial trauma. Methods Searches were conducted on Cochrane CENTRAL, Embase and Ovid MEDLINE on the 9th of October 2025 for randomised controlled trials of facial trauma containing 50 patients or more. 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 ISRCTN (International Standard Randomised Controlled Trial Number) 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 (K.C & N.B) independently performed data extraction, and outcomes reported were recorded verbatim and mapped onto the World Health Organisation International Classification of Functioning, Disability and Health (WHO ICF). Results A total of 151 distinct outcomes were identified, with a median of 4 outcomes per trial. Mapping to the WHO ICF yielded 102 outcome domains. Eighty-two studies involved the mandible only, 39 involved the midface only, 9 involved the mandible and the midface and 1 involved the midface and the frontal bone. In mandibular fracture trials, immunological system functions, which 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. Conclusion Outcome reporting in facial trauma trials is highly heterogeneous, spanning all domains of the WHO ICF framework, with limited and inconsistent use of patient-reported outcome measures. Most available PROMs were not designed specifically for facial trauma, and no single instrument is used consistently across 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.