On treatment outcomes of protraction headgear in pre-pubertal patients

Abstract

There is a consensus in the dental literature supporting the notion that facemask therapy, in general, can induce dentoalveolar, rather than skeletal effects. Alternative Rapid Maxillary Expansion and Constriction (Alt-RAMEC), was introduced by Eric Liou, with reports of potential skeletal changes. These preliminary reports on the Alt-RAMEC effect deserve thorough clinical investigation in a randomised clinical trial. In this dissertation, we conducted a randomised clinical study to test the skeletal effect of facemask therapy using the Alt-RAMEC approach in two different prepubertal groups; Group I (17 patients) with a tooth-borne rapid maxillary expander (RME) attached to a facemask and Group II (17 patients), with a skeletally anchored rapid maxillary expander attached to the facemask. In both groups, the facemask contained a sensor which was concealed in the facemask forehead pad that assessed the compliance, as hours of wear, during treatment. We also explored the clinical outcomes between the two groups and the relation between the compliance rate and clinical outcomes. Lastly, The research measured patients' oral-health related quality of life and the cost-effectiveness of the two treatment arms of the study. Comparison of each group to its baseline (T0-T1) showed a significant mean difference of 2.10 degrees for SNA in Group I. A significant mean difference of ANB was 3.9 degrees (P=0.001) for Group I and 3.1 degrees for Group II (P=0.001). Wits appraisal showed a significant mean difference (T0-T1) for Group I 4.7 degrees (0.001) and Group II 3.2 degrees (0.002). Overjet showed a significant mean difference of 5.4 mm for Group I (P<0.001) and 4.5 mm for Group II (P<0.001). Lower incisors to the mandibular plane showed a significant mean difference of -4 degrees for Group I (P=0.0023) and Group II =-6.1 (P=0.005). Nasolabial angle showed a significant mean difference of 13 degrees in Group I (P=0.028). Group I patients wore the facemask for 7.87 ± 2.88 hours per day and Group II patients wore the facemask for 6.98±2.68 hours per day. Patients’ quality of life tended to show the same trends in both groups. Group I showed a worsening in quality of life in Group I (T0-T1) with a mean difference of 10 (P=0.013) and Group II 10 (P=0.054). Similarly, Group I showed worsening in the physical limitation domain (T0-T1) 10 (P<0.001), (T0-T2) 7 ( P=0.002), (T0-T3) 7 (P=0.022), (T0-T4) 5 (P=0.022), (T0-T5) 6 (P=0.003) and (T0-T7) 6 (P=0.006). Global Domain of Group I showed significant differences (T0-T8) and ( T0-T9) 25 and 26, respectively (P=0.017 and 0.005). ICER (incremental cost-effectiveness ratio) showed higher costs for Group II. In conclusion, Alt-RAMEC approach in both groups resulted in the same or comparable skeletal and dentoalveolar outcomes. Furthermore, although the compliance rate was far less than instructed by the clinician, the short hours of wear resulted in beneficial skeletal changes.