Abstract
This prospective controlled trial aimed to evaluate the skeletal effect of 3.5-years bone anchored maxillary protraction (BAMP) in growing cleft subjects with a Class III malocclusion. Subjects and Method: Nineteen cleft patients (11.4 ± 0.7-years) were included from whom cone beam computed tomography (CBCT) scans were taken before the start of BAMP (T0), 1.5-years after (T1) and 3.5 y after (T2). Seventeen age- and malocclusion-matched, untreated cleft subjects with cephalograms available at T0 and T2 served as the control group. Three dimensional skeletal changes were measured qualitatively and quantitatively on CBCT scans. Two dimensional measurements were made on cephalograms. Results: Significant positive effects have been observed on the zygomaticomaxillary complex. Specifically, the A-point showed a displacement of 2.7 mm ± 0.9 mm from T0 to T2 (p < 0.05). A displacement of 3.8 mm ± 1.2 mm was observed in the zygoma regions (p < 0.05). On the cephalograms significant differences at T2 were observed between the BAMP and the control subjects in Wits, gonial angle, and overjet (p < 0.05), all in favor of the treatment of Class III malocclusion. The changes taking place in the two consecutive periods (ΔT1-T0, ΔT2-T1) did not differ, indicating that not only were the positive results from the first 1.5-years maintained, but continuous orthopedic effects were also achieved in the following 2-years. Conclusions: In conclusion, findings from the present prospective study with a 3.5-years follow-up provide the first evidence to support BAMP as an effective and reliable treatment option for growing cleft subjects with mild to moderate Class III malocclusion up to 15-years old.
Highlights
Children born with cleft lip and palate (CLP) are usually characterized by a Class III
A power analysis on the minimal number of subjects needed to detect a difference between the bone anchored maxillary protraction (BAMP) and the control group at T2 (3.5 y), with a power of 80% and p < 0.05, showed that 11 participants were needed to detect a difference on A-point Region of Interest (ROI) from cone beam computed tomography (CBCT) surface models, and 17 participants to detect a difference on ANB angle from cephalograms
Twenty-three consecutively treated cleft patients were included in the study
Summary
Children born with cleft lip and palate (CLP) are usually characterized by a Class III malocclusion, which is primarily the result of maxillary deficiency. The most common orthopedic treatment in both cleft and non-cleft patients with a Class III malocclusion is facemask therapy (FM) with or without rapid maxillary expansion (RME). This tooth-borne treatment modality, often used in patients with early deciduous or early mixed dentition [11,12], has been reported to have undesirable side effects such as dentoalveolar compensation and a clockwise rotation of the mandible [13,14].
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