Date of Award

9-26-2025

Department

Department of Orthodontics

First Advisor

Jonas Bianchi

First Committee Member

Heesoo Oh

Second Committee Member

Joorok Park

Abstract

Background: Orthodontic pain affects 72-100% of patients during treatment, with individual pain tolerance varying by 25-60% due to genetic factors alone. Previous studies of transcutaneous electrical nerve stimulation (TENS) for orthodontic pain have relied on between-group comparisons, failing to control for massive individual variability.Objective: To determine if an intraoral TENS device (The Dental Pain Eraser® DPE – Synapse Dental, LLC, Cranston, RI), reduces perceived pain during initial orthodontic alignment compared to split-mouth matched controls (sham device), and to identify baseline patient factors correlating with pain response severity and temporal patterns.Methods: This study was conducted with a triple-blind split-mouth randomized controlled trial. 31 patients were enrolled and underwent initial orthodontic treatment with full-fixed appliances. One randomly selected quadrant received active TENS treatment while the contralateral quadrant received sham treatment. Pain scores were assessed using the Numeric Rating Scale (0-10) at seven time points over 72 hours (T0, T2, T6, T12, T24, T48, T72). The statistical methods involved linear mixed models to analyze the device effects, while Pearson correlation analysis examined relationships between pain scores and patient characteristics including age, skeletal pattern (FMA), crowding, overbite, and incisor inclination.Results: For the perceived pain, no significant difference was found between active and sham TENS devices (p=0.964). However, correlation analysis revealed distinct temporal patterns of pain predictors. Age correlation doubled from baseline (r=0.26, p=0.007) to 72 hours (r=0.55, p< 0.001). Upper arch crowding peaked at 24 hours (r=-0.40, p< 0.001), while lower arch crowding intensified at 48 hours (r=-0.50, p< 0.001). FMA showed consistent correlation throughout (r=0.30-0.38), and overbite demonstrated protective effects peaking at 72 hours (r=-0.45, p< 0.001).Conclusions: No statistically significant differences between the TENS device and sham control were found for the perceived orthodontic initial alignment pain. The temporal evolution of pain predictors indicates multiple underlying mechanisms requiring targeted strategies based on individual risk profiles. A larger sample size is required to confirm these findings.

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