RESUMO
Objective:To investigate the efficacy and safety of SIMI mouthguard paint(test group) in the treatment of enamel demineralization during orthodontic therapy with fixed applince.Methods:152 cases underwent orthodontic therapy with fixed applince were included in a randomized,open,positive control trial,and were treated by SIMI and Duraphant fluoride toothpast (control group) respectively(n =76).The enamel opaque spot was observed before and 3 months after using the products.The oral mucosa reactions,asthma attacks or stomach nausea and other adverse events were recorded.Results:150 cases (n =75) completed the trial.The results showed that the test group was non-inferior compared with the control group.No adverse event was found in both groups.Conclusion:SIMI mouthguard paint is effective in control of enamel demineralization during orthodontic therapy with fixed applince.