Minimal clinically important difference of mouth opening in oral submucous fibrosis patients: a retrospective study.

Objectives: The purpose of this study was to estimate the minimal clinically important difference (MCID) of mouth opening (MO) and patient satisfaction in surgically treated oral submucous fibrosis (OSMF) patients. Materials and Methods: The status of MO was collected preoperatively (T0), postoperatively at 3 months (T1), and at a minimum of 6 months postoperatively (T2). MCID was determined through the anchor-based approach with the change difference method, mean change method, and receiver operator characteristic curve (ROC) method. Results: In this study, 35 patients enrolled and completed postoperative follow-up (T2) averaging a duration of 18.1 months. At T1, using the change difference method, MO was 14.89 mm and the ROC curve exhibited a 11.5 gain in MO (sensitivity 81.8% and specificity 100%, area under the curve [AUC] of 0.902) and was classified as MCID as reported by patients. At T2, MCID of MO was 9.75 mm using the change difference method and 11.75 mm by the mean change method. The ROC curve revealed that the MCID of MO at T2 was 10.5 mm with 73.9% sensitivity and 83.3% specificity (AUC of 0.873). The kappa value was 0.91, confirming reliability of the data. Conclusion: This study demonstrated MCID values that indicate the clinical relevance of surgical treatment of OSMF if the minimum possible gain in MO is approximately 10 mm.