A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 2-quality of treatment.

OBJECTIVE

To compare the quality of orthodontic treatment between 0.018-inch and 0.022-inch slot bracket systems.

SUBJECTS AND METHODS

Eligible participants aged 12 years or over were allocated to the 0.018-inch or 0.022-inch slot MBT appliance (3M-Unitek, Monrovia, California, USA) using block randomization in groups of 10. Outcome measures included: 1. ABO cast-radiograph evaluation (CR-EVAL), 2. peer assessment rating (PAR) scores, 3. incisor inclination, and 4. patient perception using the Index of Orthodontic Treatment Need aesthetic component (IOTN AC) and three validated questionnaires before, during and after treatment. Parametric tests [independent samples t-test and two-way analysis of variance (ANOVA)] and non-parametric tests (chi-square with Fisher's exact tests and Mann-Whitney U-test) assessed differences between groups (P < 0.05).

RESULTS

Of the 187 participants randomized (1:1 ratio), 34 withdrew or were excluded (protocol deviations or poor cooperation). There were 77 patients in the 0.018-inch slot group and 76 patients in the 0.022-inch slot group (overall mean age: 19.1 years). Baseline characteristics were similar between groups (P > 0.05). The mean total ABO CR-EVAL scores were 34.7 and 34.5; mean percentage PAR score reduction 74.1 per cent and 77.1 per cent; mean change for maxillary incisor inclination 2.9 degrees and 1.6 degrees and for mandibular incisor inclination 2.7 degrees and 1.4 degrees for the 0.018-inch and 0.022-inch groups, respectively. Improvement in patient perception of aesthetics after treatment was statistically significant for both groups (P < 0.05). However, there were no statistically significant differences between the two treatment groups for ABO CR-EVAL, percentage PAR score reduction, incisor inclination, and patient perception of treatment (P > 0.05). No adverse events were observed during treatment.

LIMITATIONS

It was impossible to blind clinicians or patients to allocation and oral hygiene and periodontal outcomes were not assessed.

CONCLUSIONS

There were no statistically or clinically significant differences in the quality of occlusal outcomes, incisor inclination and patient perception of treatment between 0.018-inch and 0.022-inch slot bracket systems.

REGISTRATION

The trial was registered with ClinicalTrials.gov on 5 March 2014, registration number: NCT02080338.

PROTOCOL

The protocol was published at DOI: 10.1186/1745-6215-15-389.