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

NCT07760337 | Completed

• 1 other identifier: FUCDCLINIC-2401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Transcutaneous electrical nerve stimulation; Pain; orthodontic wire

Outcome Measures

Primary Outcomes (1)

• Pain will be measured after intervention at visual analogue scale

  pateint after giving TENS treatment will be asked to measure their pain score for right and left side on visual analogue scale

  pain will be marked on visual analogue scale at 0 hour , 6 hours, 24 hours, 48 hours

Study Arms (2)

TENS group

EXPERIMENTAL

Participants in this arm will receive two 5-minute sessions of TENS therapy with a 2-minute break in between. Self-adhesive electrode pads will be placed on the designated cheek as determined by randomization. The TENS device will be set at intensity that is comfortable for the participant. The device will deliver electrical pulses through the electrodes to stimulate sensory nerves and potentially reduce pain. Participants will receive this TENS therapy application immediately after the initial placement of the alignment archwire Both groups will be instructed to mark their pain levels on a visual analog scale (VAS) at 0, 6, 24, and 48 hours after the initial archwire placement.

Device: TENS

Placebo/Control group

SHAM COMPARATOR

Participants in this arm will receive a similar treatment that mimics the TENS application but with minimal current to maintain participant blinding. Similar to the TENS group, self-adhesive electrode pads will be placed on the designated cheek. The placebo device will be set at a very low intensity that only feels like a slight tingling sensation. This sham treatment serves as a control, allowing comparison of any pain reduction to the effects of real TENS therapy.Participants will receive this placebo treatment application on the same schedule as the TENS group - immediately after archwire placement

Device: TENS

Interventions

TENS DEVICE

Trancutaneous electrical nerve stimulation device with self-adhesive pads will be placed on patients cheeks. Experimental side will recveive active TENS treatment and other side will receive treatment with intensity of TENS set at low intensity (subtherapeutic)

Placebo/Control group; TENS group

Eligibility Criteria

• Age: 18 Years - 57 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: split-mouth study design interventional or placebo control side will be selected randomly through sealed envelope by an independent researcher not involved in the study .
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Model: Parallel-Arm Design Model Description: This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive TENS therapy or a placebo treatment. They will remain in their assigned group throughout the study.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: March 20, 2024
• Primary Completion: October 2, 2024
• Study Completion: December 2, 2024
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

PA (1)