Abstract

Because of their importance in health care research, randomized controlled trials (RCTs) should be correctly labeled in the title to ensure it reflects the methodologic standards undertaken. This study aimed to assess whether orthodontic RCTs are correctly titled RCTs, and trial characteristics that influence correct labeling in titles were explored. Orthodontic RCTs published between January 1, 2015 and September 30, 2020 in 7 orthodontic journals were identified. For a trial to be considered an RCT, random allocation sequence generation and allocation concealment mechanisms should be reported in the study methodology. Trial characteristics at the RCT level were extracted, and frequency distributions were calculated for the included trial characteristics. A 2-stage continuation ratio ordinal logistic regression model was used to assess associations between the dependent variable (non-RCT, unclear, RCT) and the trial characteristics. One-hundred and seventy-three RCTs were analyzed. Of these, 112 (64.7%) were assessed as true RCTs, with 109 (64.1%) correctly labeled as RCTs. The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) published the most trials that were correctly labeled as RCTs (90.5%). In the adjusted model, the type of journal influenced the correct labeling, with all journals compared with AJODO having lower odds of correct RCT classification. Multicenter trials were associated with higher odds of being correctly labeled as an RCT. Compared with previous investigations, the correct labeling of orthodontic RCTs in the title of the report has improved substantially. The type of journal and multicenter trials influenced the correct labeling of a trial as an RCT. The number and odds of RCTs being correctly labeled as RCTs were higher in trials published in AJODO.

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