Alignment efficiency of heat activated and superelastic nickel-titanium archwires in orthodontic patients over three months: A Single-center, randomized clinical trial

OBJECTIVE: The aim of this 2-arm parallel study was to evaluate the alignment efficiency of heat-activated nickel-titanium (NiTi-TE) and superelastic nickel titanium (NiTi-PSE) archwires over the first 3 months of orthodontic treatment and compare these groups. SETTING AND SAMPLE POPULATION: Randomized, double-blind, controlled, single-center trial in 52 patients with fixed orthodontic appliances from an orthodontic graduate program in the permanent dentition and moderate crowding in the lower arch. MATERIAL AND METHODS: Patients were randomly allocated to one of two interventions: NiTi-TE and NiTi-PSE archwires, 0.014-inch (3M Unitek™, CA, USA) with a follow-up period of 3 months. The primary outcome was the alignment efficiency determined by the reduction in Little's irregularity index (mm), measured in three points, T0: before the start of orthodontic treatment, T1: 1 month later, T2: 2 months later, T3: 3 months later. Data were analyzed using independent sample t tests and repeated measures ANOVA. RESULTS: 52 patients (NiTi-TE n = 26; NiTi-PSE n = 26) were randomized and analyzed (average age: 21.73; standard deviation (SD): 6.07; average lower anterior irregularity: 5.20; SD: 0.76) for intention-to-treat (ITT) analysis. No statistically significant differences between the groups were found (mean of the differences: T1: 0.20; 95% CI: –0.558; 0.958; T2: 0.49: 95% CI: –0.339; 1.319; T3: 0.33; 95% CI: –0.308; 0.968). The resolution of crowding with each of the wires was significant (P < 0.0001) at all times. Twelve participants (2 treated with NiTi-TE and 10 treated with NiTi-PSE) lost follow-up due to face-to-face dental-procedures restrictions during the COVID-19 pandemic, the missing data was imputed. CONCLUSIONS: NiTi-TE and NiTi-PSE wires of 0.014-inch were similar in their clinical efficiency for the resolution of crowding during the first 3 months of orthodontic treatment. REGISTRATION: Clinical Trials NCT03256279.