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OpenTrials
Completed

NCT Number: NCT07687810

TENS Device Use for Discomfort Relief During Orthodontic Tooth Movement

The goal of this clinical trial is to learn if Transcutaneous Electric Nerve Stimulation (TENS) device works to reduce discomfort during orthodontic treatment, by using orthodontic separators to mimic the discomfort of braces.

The main questions it aims to answer are:

* Does TENS device lower the participants level of discomfort? * Will TENS device be effective with orthodontic tooth movement?

Researchers will place the separators on different sides of upper and lower first molars. TENS device will be applied on each participant on one of both teeth (according to their group), so that the results can be compared within the same person. Participants will:

* Visit the clinic after 12 or 24 hours (depends on their group) * Stay on dental chair while TENS device is applied. * Rate the discomfort level on VAS scale before and after TENS device application.

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Key information

Conditions

Non-Pharmacological Pain Management Orthodontic Discomfort

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajman University

Ajman, Ajman Emirate, 00000, United Arab Emirates

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Full permanent dentition excluding third molars.
  • Sound not carious nor endodontic treated contralateral first molars.
  • Interproximal contact mesial and distal to first molar present on both upper and lower molars.

Exclusion criteria

  • Dental pain.
  • Heart arrhythmias.
  • History of seizures.
  • Taking any pain medication during the test period.
  • Missing tooth excluding third molars.
  • Endodontic treated or carious first molar.
  • Spacing mesial or distal to the first molar.

Treatment and study plan

TENS Device

Other

No intervention is needed in the study. The device is being used in all groups but in different ways.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: From orthodontic separators application to 12 or 24 hours depends on the participant group.

    To rate the level of discomfort pre and post TENS device application, where 0 is equivalent to no discomfort and 10 indicates most discomfort possible (the more reduction of the level of discomfort the better for the study results).

Sponsors and collaborators

Lead sponsor

Ajman University

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation (TENS) as a Non-invasive Non-pharmacological Method to Alleviate Discomfort During Orthodontic Tooth Movement - An In-vivo Study

Acronym: TENS OTM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2026
Registry last updated
Jul 20, 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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