A Split Mouth Study to Evaluate Transcutaneous Electrical Nerve Stimulation as an Effective Non-pharmacological Approach in Managing Pain During Initial Orthodontic Treatment - A Randomized Controlled Trial

Overview

Orthodontic treatment often causes pain during the initial alignment stage which can lead to discomfort, reduced compliance, and slower treatment progress. Potential Solution: Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive, non-pharmacological approach that uses mild electrical currents to stimulate nerves and potentially reduce pain. This study uses a split-mouth design, with each patient acting as their own control. One side of their mouth receives the TENS therapy, while the other receives a placebo treatment (minimum current below the therapeutic level). This allows for a direct comparison of TENS effectiveness without the influence of individual pain variations. Research Goal: The study aims to determine whether TENS can effectively manage pain during initial orthodontic treatment. This would offer a safe and natural alternative to pain medications, potentially improving patient comfort and treatment outcomes.

Goal: This study aims to investigate the potential of Transcutaneous Electrical Nerve Stimulation (TENS) as a safe and effective non-pharmacological approach for managing pain during the initial stages of orthodontic treatment. The study will compare the pain-relieving effect of TENS therapy with a placebo treatment in a split-mouth design. This means that each participant will act as their own control, with one side of their mouth receiving TENS and the other side receiving a placebo treatment that mimics the TENS device but delivers minimal electrical current. The study will involve individuals aged 15-57 years old who are undergoing initial orthodontic treatment with alignment archwires. Participants should have good oral hygiene and no contraindications to TENS therapy, such as epilepsy, cardiac arrhythmias, or pacemakers. The primary question the study aims to answer is: Can TENS be used as an effective alternative to pain medication for managing pain during the initial stages of orthodontic treatment? Participants will undergo a thorough clinical examination and provide informed consent. Each participant's mouth will be randomly assigned to receive TENS therapy on one side and a placebo treatment on the other. The TENS group will receive two 5-minute active TENS therapy sessions with a 2-minute break in between, using self-adhesive electrode pads placed on the designated cheek as determined by randomization. The placebo group will receive a similar treatment that mimics the TENS application but with minimal current to maintain patient blinding. Participants will mark their pain levels on a visual analog scale (VAS) at 0, 6, 24, and 48 hours after the treatment. Comparison Groups and Expected Effects: TENS Group vs. Placebo Group: The researcher will compare the pain reduction reported by the TENS group and the placebo group at the specified time intervals i.e at 0, 6, 24, and 48 hours after the treatment.