Optimized and validated clinical diagnostic criteria for burning mouth syndrome

ObjectivesBurning mouth syndrome (BMS) is defined as a chronic intraoral burning sensation occurring in the absence of identifiable local or systemic causes. Several classification systems have proposed diagnostic criteria for BMS, including the International Classification of Headache Disorders (ICHD-3), the International Classification of Diseases (ICD-11), the International Classification of Orofacial Pain (ICOP-1), and the World Congress of Oral Medicine (WCOM). However, none of these have been validated. This study aims to evaluate the diagnostic performance of ICHD-3, ICD-11, ICOP-1, and WCOM criteria for BMS and to suggest optimized diagnostic criteria.MethodsWe assessed 76 consecutive patients referred for burning oral pain. Of these, 34 (28 women) were diagnosed with BMS according to the reference standard, and 42 (37 women) had other oral mucosal pain conditions. Two control groups were also recruited: 31 TMD patients (28 women) and 30 pain-free participants (26 women). Assessment involved self-report questionnaires and comprehensive clinical examinations. All patients with burning oral pain underwent additional laboratory tests. Consensus-based diagnosis constituted the reference standard, and a blinded examiner applied each set of different diagnostic criteria as the index tests. We calculated sensitivity, specificity, positive (PPV) and negative predictive values (NPV), and positive and negative likelihood ratios (LR + and LR-), and the area under the ROC curve for each index tests. Because some ICHD-3 criteria were ambiguously defined, we created operational definitions and tested three versions of the criteria.ResultsNo significant group differences were found in age, sex, or smoking status. None of the criteria exhibited both high sensitivity and specificity. WCOM showed the highest sensitivity (91.2%), NPV (99.2%), LR- (0.14), and AUC (0.717). In contrast, ICHD-3 definition 3 showed the highest specificity (93.2%), PPV (8.2%), and LR + (5.2), but the lowest sensitivity (35.3%). Based on these findings, we developed an optimized version of the ICOP criteria. The new criteria showed the highest sensitivity (94.1%), NPV (99.9), LR- (0.07), and AUC (0.874), while maintaining acceptable specificity (79.6%), PPV (7.4%), and LR + (4.4).ConclusionSubstantial variation exists in the diagnostic performance of current BMS criteria, with each set showing either high sensitivity or specificity. This study provides the first data-driven proposal for modified diagnostic criteria for BMS, offering a foundation for improving future versions of ICHD and ICOP.