Completed

NCT Number: NCT07760337

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

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.

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Key information

Conditions

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

Age range

18 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University Islamabad

Islamabad, Federal, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- both male and female patients Age 18-57 years Good oral hygiene Patients in alignment and levelling stage Patients how have not taken any pain medication in the past 24 hours

Exclusion criteria

- Patients with history of epilepsy Patients with cardia arrhythmias and pacemaker Pregnant patients

Treatment and study plan

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)

Primary outcomes

Pain will be measured after intervention at visual analogue scale

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

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

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Acronym: TENS

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Aug 12, 2026
Registry last updated: Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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