Vital staining adjuncts to determine the need for biopsy for early detection of oral squamous cell carcinoma and potentially malignant disorders: An evidence summary of a living systematic review, Version 2026 1.0

Background: Improvements in disease progression and treatment can coincide with the early detection of oral potentially malignant disorders and oral squamous cell carcinoma. Although biopsy is the standard for diagnosing these conditions, adjuncts like vital staining are less invasive and could potentially indicate when biopsy is necessary. In this living systematic review, the authors summarize the diagnostic test accuracy and impact of vital staining among adults with or without lesions. Types of Studies Reviewed: The authors searched MEDLINE, Epistemonikos, Embase, and Cochrane Central Register of Controlled Trials through November 25, 2025. Independent paired reviewers selected studies, extracted data, and assessed risk of bias. The authors assessed the certainty of the evidence using the Grading of Recommendations Assessment, Development and Evaluation approach and reported results in summary of findings tables. Results: In 1 study, the researchers evaluated the impact of vital staining, specifically toluidine blue, to screen adults without lesions. No adverse events (moderate certainty) were reported. The rate ratio for oral cancer incidence was 0.79 (95% CI, 0.24 to 1.23; low certainty) and 0.31 (95% CI, 0.03 to 2.94; very low certainty) for malignant transformation. The authors included 36 studies on diagnostic test accuracy in adults with lesions. The pooled sensitivity and specificity (2,770 lesions, 35 studies) was 0.86 (95% CI, 0.80 to 0.90; very low certainty) and 0.69 (95% CI, 0.60 to 0.76; very low certainty), respectively. Conclusions and Practical Implications: The effects of vital staining in people with and without lesions in primary care settings are very uncertain due to serious risk of bias and indirectness. Among adults with lesions, the data suggest many false-positive results are expected, which are associated with downstream consequences like unnecessary biopsies and emotional burden.