Efficacy of clear aligners vs rapid palatal expanders on palatal volume and surface area in mixed dentition patients: A randomized controlled trial
Abstract
INTRODUCTION
This study aimed to evaluate the efficacy of Invisalign First Phase I treatment compared with tooth-borne rapid maxillary expansion (RME) in mixed dentition patients by examining changes in palatal volume, palatal surface area, and maxillary interdental transverse measurements.
METHODS
In this open-label, 2-arm, parallel, randomized controlled trial, patients with a posterior transverse discrepancy ≤6 mm were allocated into the clear aligner therapy (CAT) group (Invisalign First Phase I treatment) and RME group (tooth-borne RME) according to a computer-generated randomization list immediately before the start of treatment. Digital models were obtained before the beginning of the treatment (T0) and at the end of the retention period/treatment (T1) using an intraoral scanner. Palatal volume was measured as the primary outcome, and palatal surface area and intermolar and intercanine transverse widths at the cusps and gingival level were measured as secondary outcomes. Patients and interventionists were not blinded because of the nature of the intervention.
RESULTS
Out of 50 patients, 41 (19 males and 22 females; mean age, 8.12 ± 1.53 years) were enrolled and divided into 2 groups: 20 in the CAT group and 21 in the RME group. Two participants did not receive the allocated intervention for different reasons (1 patient discontinued the intervention in the CAT group, and another patient was lost to follow-up in the RME group). Thus, 19 patients (5 males and 14 females;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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