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COMPLETED
NCT07760337
NA

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

Sponsor: Foundation University Islamabad

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 57 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-03-20

Completion Date

2024-12-02

Last Updated

2026-08-12

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

TENS

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)

Locations (1)

Foundation University Islamabad

Islamabad, Federal, Pakistan