Assessment of the changes in arch perimeter and irregularity in the mandibular arch during initial alignment with the AcceleDent Aura appliance vs no appliance in adolescents: A single-blind randomized clinical trial.

INTRODUCTION

The purpose of this 2-arm parallel trial was to assess the effects of the AcceleDent Aura (OrthoAccel Technologies, Houston, Tex) appliance on the increase in mandibular anterior arch perimeter, the reduction in mandibular arch irregularity, and the amount of discomfort during initial alignment of the mandibular arch with fixed appliances.

METHODS

Forty Class II adolescent patients with full fixed appliances and treated with maxillary premolar extractions and no extractions in the mandibular arch participated in this randomized clinical trial. They were recruited in a private practice and treated by 1 clinician. Randomization to either a no-appliance group or the AcceleDent Aura appliance group was accomplished with permuted blocks of 10 patients with the allocations concealed in opaque, sealed envelopes. Both the operator and the outcome assessor were blinded, but it was not feasible to blind the patients. Discomfort was recorded during the first week of treatment. Mandibular anterior arch perimeter and anterior irregularity were measured from plaster models taken at the start of treatment and after 5, 8, and 10 weeks.

RESULTS

No patients were lost to follow-up, and no data were missing. There was no difference in anterior arch perimeter at the start of treatment (P = 0.85; median, 0.6 mm; 95% confidence interval [CI], -1.6, +1.8 mm) or at any other time point (5 weeks: P = 0.84; median, -0.2 mm; 95% CI, -1.6, +1.2 mm; 8 weeks: P = 0.56; median, -0.3 mm; 95% CI, -1.6, +0.7 mm; 10 weeks: P = 0.67; median, -0.1 mm; 95% CI, -1.5, +1.1 mm). There was also no difference between groups for incisor irregularity (P = 0.46; median, -0.5 mm; 95% CI, -2.2, +2.8 mm; P = 0.80; median, 0.0 mm; 95% CI, -1.0, +1.1 mm; P = 0.70; median, 0.1 mm; 95% CI, -0.7, +0.8 mm; P = 0.65; median, 0.2 mm; 95% CI, -0.6, +0.6 mm). No difference was detected at any time during the first week for discomfort (baseline: P = 0.84; median, -1.5 mm; 95% CI, -15.9, +9.8 mm; 6 hours: P = 0.96; median, 0.3 mm; 95% CI, -23.5, +21.8 mm; 1 day: P, 0.75; median, -3.5 mm; 95% CI, -27.1, +26.9 mm; 3 days: P = 0.98; median, -0.6 mm; 95% CI, -20.6, +20.0; 7 days: P = 0.57; median, 0.5 mm; 95% CI, -5.0, +5.3 mm). However, significantly fewer participants in the AcceleDent Aura group used analgesics at day 1 (P = <0.01).

CONCLUSIONS

The AcceleDent Aura appliance had no effect compared with no appliance on increasing anterior arch perimeter, or reducing irregularity or perceived discomfort during initial alignment with fixed appliances, although more subjects used painkillers at 24 hours in the no-appliance group.

REGISTRATION

This trial was not registered.

PROTOCOL

The protocol was not published before trial commencement.

FUNDING

A special research grant was obtained from the Australian Society of Orthodontists Foundation for Research and Education to purchase the AcceleDent Aura appliances and fund the statistical analysis.