Non-Pharmacological Pain ManagementTENS OTMNCT07687810
TENS Device Use for Discomfort Relief During Orthodontic Tooth Movement
A study testing TENS Device in people with Non-Pharmacological Pain Management and Orthodontic Discomfort, run by Ajman University at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Pharmacological Pain Management, Orthodontic Discomfort
- What is being tested?
- TENS Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 28 Feb 2024to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Ajman University
Ajman, Ajman Emirate, 00000
About this study
Official title: 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:
Read more
- 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.
- Being tested
- TENS Device
- Keywords
- TENS, Orthodontic Treatment, Non-pharmacological pain management, Orthodontic Discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS DeviceOther
No intervention is needed in the study. The device is being used in all groups but in different ways.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: TENS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From orthodontic separators application to 12 or 24 hours depends on the participant group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start28 Feb 2024
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Pharmacological Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeny M George, MDS, Principal investigator, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687810
- Sponsor's protocol ID
- D-H-S-2023-DEC-6-24
- Acronym
- TENS OTM
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) as a Non-invasive Non-pharmacological Method to Alleviate Discomfort During Orthodontic Tooth Movement - An In-vivo Study
- ClinicalTrials.gov ID
- NCT07687810
- Acronym / sponsor ID
- TENS OTM / D-H-S-2023-DEC-6-24
- Keywords
- TENS, Orthodontic Treatment, Non-pharmacological pain management, Orthodontic Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 12 Hours Maxilla | Experimental | Other: TENS DeviceParticipants recalled after 12 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control). |
| 12 Hours Mandible | Experimental | Other: TENS DeviceParticipants recalled after 12 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control). |
| 24 Hours Maxilla | Experimental | Other: TENS DeviceParticipants recalled after 24 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control). |
| 24 Hours Mandible | Experimental | Other: TENS DeviceParticipants recalled after 24 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Dental pain.
- Heart arrhythmias.
- History of seizures.
- Taking any pain medication during the test period.
- Missing tooth excluding third molars.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS DeviceNo intervention is needed in the study. The device is being used in all groups but in different ways. | Other | 12 Hours Mandible, 12 Hours Maxilla, 24 Hours Mandible, 24 Hours Maxilla |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeny M George, MDS principal investigator
Ajman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS Device in people with Non-Pharmacological Pain Management and Orthodontic Discomfort, run by Ajman University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: From orthodontic separators application to 12 or 24 hours depends on the participant group.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.