Do patient-reported outcomes of miniscrew-supported maxillary expansion in adolescent patients differ between slow and rapid activation protocol?

DESIGN: Single-center randomized clinical trial with two parallel arms. The protocol of the study was approved by the institutional review board (IRB) of the Faculty of Dentistry, Alexandria University (IRB: 00010556-IORG: 0008839) and registered in Clinicaltrials.gov (identifier number: NCT04225637). Before the trial commencement, parents/legal guardians signed informed consents. The study complied with the CONSORT (Consolidated Standards of Reporting Trials). CASE SELECTION: 30 adolescent patients aged between 12 to 16 years with transversely deficient maxilla requiring skeletal maxillary expansion were recruited to be included in the study. Patients received miniscrew-supported Penn expanders and they were randomly allocated (ratio 1:1) into two groups based on the activation protocol; slow maxillary expansion (SME = turn every other day) or rapid maxillary expansion (RME = 2 turn/day). DATA ANALYSIS: The patient-reported outcome measures were the following: pain, headache, pressure, dizziness, speech, chewing and swallowing difficulties, swallowing difficulty. The participants rated the reported outcomes using numeric rating scale (NRS) at 4 time points: t(1) = before appliance insertion, t(2) = after first activation, t(3) = after 1 week of activation, and t(4) = after last activation. Patients were advised not to use analgesics, and to contact their provider in case of severe pain. Descriptive measures and patient-reported outcomes at various time points were calculated. Comparisons between the two groups at each time point were assessed using Mann-Whitney U-test. Comparisons of time points in each group were assessed using the Friedman test and followed by post-hoc tests with Bonferroni correction. RESULTS: 6 patients were not included in the analysis for different reasons, allowing a total of 24 patients (12 patients in each group) to be analyzed. Mean ages of the patients in the SME and RME group were 14.30 +/- 1.37 and 15.07 +/- 1.59, respectively. Median scores were in the bottom quartiles of NRS for all reported outcomes. RME group reported significantly higher scores for all measured variables, with exception of headache and dizziness, which showed no statistical difference between the two group. CONCLUSIONS: Mild to moderate discomfort and functional limitation is anticipated with the activation of miniscrew-anchored Penn expanders. Slow activation protocol provided a better overall patient experience when compared to a rapid activation protocol.