RESUMO
INTRODUCTION: The objective of this 4-arm parallel study was to evaluate the alignment efficiency and esthetic performance of 4 coated nickel-titanium archwires over an 8-week period. METHODS: Patients in the permanent dentition requiring maxillary and mandibular fixed orthodontic treatment with a preadjusted edgewise appliance were eligible for inclusion. Patients attending 4 hospital departments (United Kingdom and Italy) were randomly allocated to 1 of 4 treatment interventions: (1) BioCosmetic (Forestadent, Pforzheim, Germany), 0.017 in; (2) Titanol (Forestadent), 0.016 in; (3) TP Aesthetic (TP Orthodontics, La Porte, Ind), 0.014 in; and (4) Tooth Tone (Ortho Organizers, Calsbad, Calif) 0.016 in. Block randomization with block sizes of 4 and 8 was used to ensure an allocation ratio of 1:1:1:1. The primary outcome was alignment efficiency determined by the reduction in Little's irregularity index (mm). Secondary outcomes were color change using the Commission Internationale de L'Eclairage L*a*b* system and percentage of coating loss. Blinding was only applicable to outcome assessment of alignment efficiency. Regression models with Sidak's multiple comparison of means were used to analyze the data. RESULTS: One hundred fifty patients (300 dental arches) were allocated to the treatment interventions, including 61 male and 89 female subjects with a mean age of 16.60 years. The average duration of follow-up was 63.65 days. Baseline characteristics for the archwire groups were similar. One patient was lost to follow-up. Five percent (n = 15) of the archwires fractured: BioCosmetic, 5.3% (n = 4); Titanol, 6.8% (n = 5); TP Aesthetic, 5.3% (n = 4); and Tooth Tone, 2.7% (n = 2). We analyzed 283 dental arches for alignment efficiency. There was no statistically significant difference for mean reduction in irregularity between the archwire groups (P = 0.627): BioCosmetic (n = 71), 3.86 mm (95% CI, 3.31-4.41); Titanol (n = 69), 4.51 mm (95% CI, 4.00-5.02); TP Aesthetic (n = 71), 4.13 mm (95% CI, 3.49-4.78); and Tooth Tone (n = 72), 4.21 mm (95% CI, 3.89-4.46). There was a statistically significant difference between archwire groups for color change (P = 0.001) and percentage of coating loss (P = 0.001), with BioCosmetic performing best in both parameters. CONCLUSIONS: There was no difference between the archwires for alignment efficiency. BioCosmetic performed statistically significantly better than did the other groups for both color change and coating loss. REGISTRATION: This trial was registered with the East Midlands NHS Research Ethics Committee (12/EM/0190). PROTOCOL: The protocol was not published before trial commencement.