TENS Device Use for Discomfort Relief During Orthodontic Tooth Movement (TENS OTM)
July 17, 2026 updated by: Ajman University
Transcutaneous Electrical Nerve Stimulation (TENS) as a Non-invasive Non-pharmacological Method to Alleviate Discomfort During Orthodontic Tooth Movement - An In-vivo Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, United Arab Emirates, 00000
- Ajman University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 12 Hours Maxilla
Participants recalled after 12 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control).
|
No intervention is needed in the study.
The device is being used in all groups but in different ways.
|
|
Experimental: 12 Hours Mandible
Participants recalled after 12 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control).
|
No intervention is needed in the study.
The device is being used in all groups but in different ways.
|
|
Experimental: 24 Hours Maxilla
Participants recalled after 24 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control).
|
No intervention is needed in the study.
The device is being used in all groups but in different ways.
|
|
Experimental: 24 Hours Mandible
Participants recalled after 24 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control).
|
No intervention is needed in the study.
The device is being used in all groups but in different ways.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
From orthodontic separators application to 12 or 24 hours depends on the participant group.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeny M George, MDS, Ajman University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2024
Primary Completion (Actual)
April 17, 2024
Study Completion (Actual)
April 17, 2024
Study Registration Dates
First Submitted
June 30, 2026
First Submitted That Met QC Criteria
June 30, 2026
First Posted (Actual)
July 7, 2026
Study Record Updates
Last Update Posted (Actual)
July 20, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- D-H-S-2023-DEC-6-24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.