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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-12

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Foundation University Islamabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
57 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2024-10-02
Completion
2024-12-02

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760337 on ClinicalTrials.gov