The clinical effectiveness and cost analysis of using two clear aligners materials: a randomized clinical trial / Dr Nabilla Mohd Shukor

ntroduction: No one aligner material is the same. This randomized clinical trial evaluated the clinical effectiveness and cost analysis between Erkodur and Zendura FLX including m aterial, chair side time and the breakages in clear aligner treatment. Methods: 19 adult participants were randomized (15 females and 4 males, 29.73 (SD8.44) years old) into two groups. Medit Design software (version 2.1) was used to measure the efficacy of orthodontic tooth movement by performing superimposition of predicted and achieved outcome. Data related to demographics, tooth movement accuracy and the related costs were recorded. The cost for each material was calculated by dissecting the costs involved in producing similar clinical outcome. Results: The mean accuracy of tooth movement with Erkodur and Zendura FLX was comparable with no statistical differences in horizontal movement from T1 to T6 and vertical movement from T1 to T4 with p < 0.05. As the treatment advanced to T5 and T6, there was a statistically significant difference between Erkodur and Zendura FLX in vertical movement, with mean differences of 0.05mm in extrusion (p = 0.036). Total cost for raw material of each plastic sheet is RM9.03 for Erkodur and RM29.32 for Zendura FLX respectively. Erkodur chair side time duration was longer (131 minutes SD 53.4) than Zendura FLX's (105.6 minutes SD 21.9). Despite having longer chairside mean time score 25.4 min more than Zendura FLX. there was no significant difference in chairside time when both groups were compared (p = 0.201). Nevertheless, the average cost of treatment with Erkodur rises by RM95.97 because of the increase in chair side time (p = 0.013). Emergency visit for Erkodur was 1.3 times higher when compared to Zendura FLX since no emergency visits were documented during the first 6 months of therapy for Zendura FLX group (p <0.05). Conclusions: The accuracy of tooth movement is comparable between Erkodur and Zendura FLX. Cost incurred in providing clear aligner treatment with Zendura FLX is higher compared to Erkodur by half. Treatment duration rose in the Erkodur group because emergency visits were twice as often as in the Zendura FLX group, adding to the overall treatment cost.