TENS Device Use for Discomfort Relief During Orthodontic Tooth Movement

NCT07687810 | Completed

• 1 other identifier: D-H-S-2023-DEC-6-24
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Pharmacological Pain Management; Orthodontic Discomfort

Keywords

TENS; Orthodontic Treatment; Non-pharmacological pain management; Orthodontic Discomfort

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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.

Study Arms (4)

12 Hours Maxilla

EXPERIMENTAL

Participants recalled after 12 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control).

Other: TENS Device

12 Hours Mandible

EXPERIMENTAL

Participants recalled after 12 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control).

Other: TENS Device

24 Hours Maxilla

EXPERIMENTAL

Participants recalled after 24 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control).

Other: TENS Device

24 Hours Mandible

EXPERIMENTAL

Participants recalled after 24 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control).

Other: TENS Device

Interventions

TENS Device OTHER

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

12 Hours Mandible; 12 Hours Maxilla; 24 Hours Mandible; 24 Hours Maxilla

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

Ajman University

Ajman, Ajman Emirate, 00000, United Arab Emirates

Location

Study Officials

• Jeny M George, MDS

  Ajman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants don't know which group they are assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study used a simple random sampling method. Each participant will have orthodontic separators applied medial and distal to contralateral first molars. Then each participant will have TENS device applied to one of the contralateral first molars (according to their group), making the other first molar of each participant to act as their own control.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: February 28, 2024
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: July 20, 2026

Record last verified: 2026-06

Locations

AE (1)