PURPOSE To investigate the effect of early correction with Twin-block appliance on soft and hard tissues of patients with Class Ⅱ skeletal malocclusion. METHODS Sixty patients with Angle Class Ⅱ skeletal malocclusion were prospectively selected. The patients were divided into 2 groups, 30 cases in each group, by random number table method. Patients in the experimental group were treated with a Twin-block appliance combined with straight wire appliance, while patients in the control group were treated with a straight wire appliance. The soft and hard tissue indexes(SNA, SNB, ANB, U1-NA angle, U1-NA distance, L1-NB distance, L1-NB angle, U1-L1) before, and 12 months after treatment were measured. Soft tissue measurement indicators included UL-U1, LL-L1, over jet, overbite, E-upper-lip from the upper lip to the E-line, and the lower lip to the E-line, changes in the vertical distance (E-lower-lip), the dip angle of the sulcus, and the thickness of the soft tissue. SPSS 25.0 software package was used for statistical analysis of the data. RESULTS U1-NA, U1-NA, L1-NB, L1-NB, overjet, overbite, E-upper-lip, and E-lower-lip were significantly less than the control group at 12 months and 36 months after treatment in the experimental group(P<0.05). U1-L1, nasolabial angle, sulcus angle, and soft tissue thickness of the experimental group were significantly greater than those of the control group(P<0.05). CONCLUSIONS Twin-block appliance combined with straight wire appliance can significantly improve the relationship between the jaw and the soft and hard tissues of patients with Class Ⅱ skeletal malocclusion, and the long-term effect is good.