Orthodontics with Customized versus Noncustomized Appliances: A Randomized Controlled Clinical Trial.

This randomized controlled trial aimed to evaluate the duration and outcome quality of orthodontic treatment with a customized fixed appliance system versus a noncustomized system. Patients ( n = 180) were randomized and received orthodontic treatment with the Insignia customized orthodontic system or the Damon Q noncustomized orthodontic system. The allocation sequence was concealed using identical, sequentially numbered, opaque, sealed envelopes. Patients with nonextraction treatment plans were treated by 2 equally experienced orthodontists. Pretreatment and posttreatment plaster casts were made for each patient, and the models were rated using the Peer Assessment Rating (PAR) score. Planning time, treatment duration, and numbers of loose brackets, visits, and complaints were recorded. The examined null hypothesis was that the customized appliance system was not associated with significantly ( P < 0.05) shorter treatment duration compared to a noncustomized appliance. We analyzed 85 patients in the customized group and 89 in the noncustomized group. Treatment duration was 1.29 ± 0.35 y in the customized group and 1.24 ± 0.37 y in the noncustomized group. In the customized group, the PAR score was 23.32 ± 9.15 pretreatment and 5.38 ± 3.75 posttreatment. In the noncustomized group, the PAR score was 21.84 ± 7.95 pretreatment and 5.93 ± 3.58 posttreatment. None of these outcomes significantly differed between groups. On the other hand, the orthodontist had a significant effect on treatment duration, quality of treatment outcome, and number of visits ( P < 0.05). A higher PAR score pretreatment was associated with increased treatment duration, posttreatment PAR, and number of visits ( P < 0.05). Compared to the noncustomized group, the customized group had more loose brackets, a longer planning time, and more complaints ( P < 0.05). The customized orthodontic system was not associated with significantly reduced treatment duration, and treatment quality was comparable between the 2 systems ( ClinicalTrials.gov : NCT01268852).

RCT Entities:   Population Interventions Outcomes