Abstract
BACKGROUND: Recent years have witnessed a remarkable evolution of clear aligner technology and clear aligners are becoming more and more versatile in treating orthodontic patients. The aim of this study was to develop an objective evaluation system for assessing clear aligner treatment difficulty. METHODS: A total of 120 eligible patients (100 patients for developing and testing the evaluation system and 20 patients for validating this system) were recruited in this retrospective cross-sectional study. Based on clinical data (dental models, radiographs and photographs), complexity levels of cases were evaluated by two experts and regarded as the gold standard. Difficulty scores were determined through an evaluation system encompassing three domains (dental model analysis, radiographic examinations and clinical examinations). The reliability of the evaluation system was examined through analyzing the agreement between complexity levels and difficulty scores. Moreover, multivariable linear regression test was used to examine the independent association of each variable (e.g. overbite and crowding) with the complexity level. RESULTS: The results revealed that the assessment of treatment difficulty by this objective evaluation system substantially matched the gold standard (R(2) = 0.80). The multivariable regression test revealed that complexity level was significantly associated with difficulty score (p < 0.001), age (p = 0.015), tooth extraction (p < 0.001), treatment stage (p < 0.01) and the number of difficult tooth movement (p = 0.005). This objective evaluation system elaborated in this study was viable and reliable in appraising clear-aligner treatment difficulty in clinical practice. CONCLUSIONS: We suggest orthodontists and general practitioners use this objective evaluation system (CAT-CAT) to appraise clear aligner treatment difficulty and to select appropriate clear aligner patients.