Alignment efficiency and esthetic performance of 4 coated nickel-titanium archwires in orthodontic patients over 8 weeks: A multicenter randomized clinical trial
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.