The aim of this study was to evaluate skeletal, dentoalveolar, and soft tissue profile changes with activator and high-pull headgear combination therapy in patients with Class II malocclusions caused by maxillary prognathism and mandibular retrognathism. The subjects, all in the mixed dentition, were selected from a single centre and were divided into two groups: 28 patients were treated with an incisor double capping activator and a high-pull headgear combination appliance (13 girls, 15 boys mean chronological age 11.7 +/- 1.2 years, skeletal age 12.1 +/- 1.4 years) and an untreated group of 28 subjects (14 girls, 14 boys mean chronological mean age 11.9 +/- 1.1 years, skeletal age 12.3 +/- 1.3 years). The skeletal, dentoalveolar, and soft tissue profile changes that occurred were compared on lateral cephalograms taken before treatment (T0) and after 1.1 +/- 0.3 years when the combination appliance was removed (T1). In the control group, the radiographs were obtained at the start (T0) and after an observation period 1.2 +/- 0.4 years (T1). Statistical analysis was undertaken with Wilcoxon's ranked-sum test for intra-group comparisons and differences between groups with t-test and Bonferroni's test at a level of significance of P < 0.05. Activator and high-pull headgear combination treatment in these growing patients resulted in a correction of the skeletal Class II relationship (ANB -3.4 degrees), a restriction of maxillary growth (SNA -2.0 degrees, OLp-A -2.3 mm), an advancement of the mandibular structures (SNB +2.6 degrees, FH-NPg +2.3 degrees, OLp-B +2.7 mm, OLp-Pg +2.2 mm), an increase in lower face height (ANS-Me +3.9 mm), a correction of the overjet (-5.4 mm), an improvement in overbite (-2.2 mm), uprighting of the maxillary incisors (U1-FH -5.3 degrees, OLp-U1 -2.5 mm), protrusion of the mandibular incisors (IMPA +2.0 degrees, OLp-L1 +2.7 mm), and a correction of the dental Class II malocclusion (OLp-L6 +3.5 mm). The soft tissue profile changes were a correction of facial convexity (G'-Sn-Pg' angle 2.3 degrees, Mlf-Li-x-axis angle 9.1 degrees), and an increase in lower antero-posterior (Mlf-y-axis 5.6 mm, Pg'-y-axis 5.3 mm), and lower vertical (Sls-x-axis 3.8 mm, Pg'-x-axis 3.8 mm, Me'-x-axis 5.1 mm) soft tissue dimensions. The mentolabial fold depth (Mlf-E line) also significantly decreased, -0.8 mm in the treated group. The activator and high-pull headgear combination appliance was effective in treating growing patients with maxillary prognathism, mandibular deficiency, and facial convexity by a combination of skeletal and dentoalveolar changes and improvement in the soft tissue facial profile.
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