Effectiveness of pulsed electromagnetic field for pain caused by placement of initial orthodontic wire in female orthodontic patients: A preliminary single-blind randomized clinical trial.

ABSTRACT

INTRODUCTION: The purpose of this 2-arm parallel trial was to assess the effects of pulsed electromagnetic field (PEMF) on the reduction of pain caused by initial orthodontic tooth movement. METHODS: Thirty-three female patients (mean age, 16.8 ± 3.8 years) who began orthodontic treatment using fixed appliances were examined. In the pilot study, male patients were less likely to use the PEMF device (epatchQ; Speed Dental, Seoul, Korea) and answer a survey consistently, so eligibility criteria were female patients who were periodontally and systemically healthy at the initiation of treatment and had no history of dental pain in the prior 2 weeks or who used no medications (anti-inflammatory or analgesic drugs) during the experiment period. Each patient had brackets bonded on the maxillary teeth, and a 0.014-in nickel-titanium archwire was tied with elastomeric rings. Their maxillary arches were randomly divided into left and right sides in a split-mouth design: a normal PEMF device (experimental group) was used on 1 side, and a PEMF device with an inversely inserted battery (placebo group) was used on the opposite side of the arch for 7 hours on 3 consecutive nights. A Google survey link was sent to the patients' mobile phones via text message, and they were instructed to record their current pain on the survey. The survey was sent a total of 6 times after insertion of the initial archwire at 0 (T0), 2 (T1), 6 (T2), 24 (T3), 48 (T4), and 72 (T5) hours. Patients recorded the degree of pain in resting and clenching states using a numeric rating scale (NRS) from 1 (no pain) to 10 (worst pain). PEMF devices were used after T2. Generalized linear mixed models, along with ancillary pairwise analyses, were used to model and evaluate the differences in pain reported over 72 hours. RESULTS: The NRS scores did not differ across the groups during the before-PEMF phase for resting (mean difference, -0.07; 95% confidence interval [CI], -0.73 to 0.59; P = 0.842) and clenching (mean difference, -0.28; 95% CI, -1.11 to 0.56, P = 0.513). During the after-PEMF phase, NRS scores in the experimental group were significantly lower than those in the placebo group during both resting (mean difference, -1.46; 95% CI, -2.06 to -0.85; P = <0.001) and clenching (mean difference, -1.88; 95% CI, -2.74 to -1.02, P = <0.001). The NRS scores did not differ across the groups during the before-PEMF phase for either state but were significantly lower in the experimental group than in the placebo group at T3, T4, and T5 (P <0.01). The average NRS score in the clenching state was significantly greater than in the resting state. CONCLUSIONS: PEMF was effective in reducing orthodontic pain caused by initial archwire placement. REGISTRATION The trial was not registered. PROTOCOL The protocol was not published before trial commencement.