Orthodontic ApplianceNCT06573996
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
A study testing Active TENS Device in people with Orthodontic Appliance and Pain, run by University of the Pacific at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine whether an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device can reduce pain during orthodontic alignment and leveling in adolescents and adults. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance, Pain, Transcutaneous Electric Nerve Stimulation
- What is being tested?
- Active TENS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General Health: Patients who are generally healthy.
- Orthodontic Treatment: Patients undergoing orthodontic treatment that requires the use of full-fixed appliances.
- No Pain Medication: Patients not currently taking any medications for pain management.
Who cannot join
- Patients with a history of seizures
- Patients with or with a history of cardiac arrhythmias or pacemaker treatment
- Patients taking any over-the-counter or prescription pain medication during the testing period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of the Pacific, Arthur A. Dugoni School of Dentistry
San Francisco, California, 94103
Jonas Bianchi, DDS, msc, phD, 415.929.6556, jbianchi@pacific.edu
German Moncada, 4156856161, gmoncada@pacific.edu
About this study
Official title: The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial
The goal of this clinical trial is to determine whether an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device can reduce pain during orthodontic alignment and leveling in adolescents and adults. The study aims to compare the effectiveness of the TENS device in reducing pain on one side of the mouth, where the device is used, to the other side, where a non-functioning (placebo) device is applied.
The primary questions this study aims to answer are:
Read more
Does the TENS device effectively reduce pain during orthodontic treatment compared to the placebo? How do patients pain levels differ between the treated and untreated sides of the mouth?
Participants will:
Have an orthodontic appliance placed on their teeth. Experience the TENS device being applied to one side of their mouth for 2.5 minutes immediately after the appliance placement (brackets and wires).
Report their pain levels at various intervals after the procedure (immediately, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours).
This study includes up to 150 participants who are undergoing routine orthodontic treatment. The findings will help researchers understand whether the TENS device can effectively reduce discomfort during orthodontic procedures, potentially leading to better patient care and comfort.
Read the detailed description
This randomized, triple-blind, split-mouth clinical trial investigates the efficacy of an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device in reducing pain during orthodontic alignment and leveling. The TENS device, specifically the Dental Pain Eraser (DPE), is designed to modulate nerve activity through neuromodulation, offering a non-pharmacologic method of pain relief.
Participants in the study will undergo standard orthodontic treatment involving the placement of full fixed appliances. Immediately after placing these appliances, the TENS device will be applied to the gums on one side of the mouth for 2.5 minutes, while a placebo device (non-functioning) will be applied to the other side. The assignment of sides will be randomized to minimize bias.
Study Design:
This study is a randomized, quadruple-blind, split-mouth clinical trial designed to evaluate the effectiveness of the intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device, the Dental Pain Eraser (DPE), in reducing pain during orthodontic alignment and leveling. The trial will involve up to 150 participants, both adolescents and adults, undergoing routine orthodontic treatment.
Blinding:
The study is quadruple-blind, meaning that the investigator, participants, the clinicians applying the treatment, and the researchers analyzing the data will be unaware of which side of the mouth received the functioning TENS device versus the placebo. This blinding is critical to eliminating bias in the treatment, assessment, and analysis phases of the study.
Randomization:
Participants will be randomized to receive the TENS device on either the left or right side of their mouth, with the opposite side receiving a placebo (non-functioning) device. Randomization will be conducted using a computer-generated sequence to ensure an equal allocation of treatment across the study population.
Intervention:
TENS Device Application: The TENS device will be applied to the gums on one side of the mouth for 2.5 minutes immediately after the placement of full fixed orthodontic appliances.
Placebo Application: A placebo device that mimics the appearance and application of the TENS device but does not deliver electrical stimulation will be applied to the opposite side of the mouth for the same duration.
Pain Assessment:
Pain levels will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). Assessments will be conducted at the following time points:
Immediately after appliance placement (0 hours) 2 hours post-placement 6 hours post-placement 12 hours post-placement 24 hours post-placement 48 hours post-placement 72 hours post-placement Participants will self-report their pain levels through a standardized survey administered via Google Forms. The survey will be designed to capture both the intensity and duration of pain experienced on each side of the mouth.
Data Collection and Management:
Data will be collected electronically and stored securely with password protection. Each participant's data will be de-identified, and only authorized research personnel will have access to the raw data. Pain ratings will be compiled into a spreadsheet for analysis, with data entry monitored to ensure accuracy.
Statistical Analysis:
The primary analysis will compare the pain levels between the side treated with the functioning TENS device and the placebo side. Paired t-tests will be used to assess the significance of any differences in pain levels. Secondary analyses may include subgroup analyses based on age, gender, and other demographic factors. The level of significance will be set at 0.05.
Detailed Description:
This randomized, triple-blind, split-mouth clinical trial investigates the efficacy of the Dental Pain Eraser (DPE), an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device, in reducing pain associated with orthodontic alignment and leveling. The DPE device is designed to provide a non-pharmacologic method of pain relief by modulating nerve activity through neuromodulation.
The trial involves up to 150 participants, including adolescents and adults, who are undergoing routine orthodontic treatment with full fixed appliances. The study's split-mouth design allows for intra-subject comparisons, enabling a direct assessment of the TENS device's effectiveness in pain management.
Participants will be randomly assigned to receive the TENS device on one side of their mouth, with the opposite side receiving a placebo device. Both the TENS and placebo devices will be applied for 2.5 minutes immediately after the placement of orthodontic appliances. The study is quadruple-blind, ensuring that neither the investigator, participants, clinicians, nor statisticians know which side received the active treatment.
Pain levels will be measured using a Numeric Rating Scale (NRS) at multiple time points following the orthodontic procedure. The primary outcome measure is the difference in pain levels between the treated and untreated sides of the mouth. Data will be collected via electronic surveys and analyzed using paired t-tests to determine the significance of any differences observed.
The results of this trial are expected to provide valuable insights into non-pharmacologic pain management strategies in orthodontics, potentially leading to improved patient outcomes and satisfaction.
- Conditions
- Orthodontic Appliance, Pain, Transcutaneous Electric Nerve Stimulation, Orthodontic Appliance Complication
- Being tested
- Active TENS Device, Intervention 2: Placebo/Sham Device
- Keywords
- Orthodontic Pain, TENS Therapy, Orthodontic Alignment, Randomized Clinical Trial, Transcutaneous Electrical Nerve Stimulation (TENS), Dental Pain Eraser
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TENS DeviceDevice
Description: The active TENS device, specifically the Dental Pain Eraser (DPE), is applied to the gums for about 2.5 minutes. This intervention is designed to modulate nerve activity to reduce pain during orthodontic alignment and leveling.
Arms Associated:
Arm 1: Upper Right Side - Active TENS Device Arm 3: Lower Right Side - Active TENS Device
Intervention 2: Placebo/Sham DeviceDevice
The placebo/sham device is identical in appearance to the TENS device but does not deliver electrical stimulation. It is applied to the gums for 2.5 minutes to serve as a control.
Arms Associated:
Arm 2: Upper Left Side - Placebo/Sham Device Arm 4: Lower Left Side - Placebo/Sham Device
| Study group | Role | What they receive |
|---|---|---|
| Upper Right Side - Active TENS Device | Experimental | Participants will receive the active TENS device on the upper right side of their mouth. This arm is designed to evaluate the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the upper arch. Receives: Device: Active TENS Device |
| Arm 2: Upper Left Side - Placebo/Sham Device | Sham comparator | Participants will receive a placebo (non-functioning) device on the upper left side of their mouth. This arm serves as a control to compare pain levels with the side receiving the active TENS device. Receives: Device: Intervention 2: Placebo/Sham Device |
| Arm 3: Lower Right Side - Active TENS Device | Experimental | Participants will receive the active TENS device on the lower right side of their mouth. This arm is intended to assess the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the lower arch. Receives: Device: Active TENS Device |
| Arm 4: Lower Left Side - Placebo/Sham Device | Sham comparator | Participants will receive a placebo (non-functioning) device on the lower left side of their mouth. This arm also serves as a control, providing a basis for comparison with the side receiving the active TENS device. Receives: Device: Intervention 2: Placebo/Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo
The primary outcome measure is the difference in pain levels between the side of the mouth treated with the active TENS device and the side treated with the placebo device. Pain levels will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement.
Secondary outcomes (1)
Duration of Pain Relief
This outcome measure will compare the duration of pain relief provided by the intraoral TENS device versus the placebo. Participants will report when they first notice a reduction in pain and how long the relief lasts on each side of their mouth. The duration of pain relief will be recorded from the time of orthodontic appliance placement until the return of discomfort or pain.
Measured: Continuously measured from the time of appliance placement up to 72 hours post-placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start16 Sep 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Orthodontic ApplianceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a split-mouth, parallel design, where each participant serves as their own control. The active treatment (TENS device) is applied to one side of the mouth, while a placebo (non-functioning device) is applied to the other side, both during the same session. The allocation of sides (left or right) for the active treatment versus placebo is randomized. This design allows for direct intra-subject comparison of pain levels between the treated and untreated sides, minimizing variability in pain perception and enhancing the reliability of the study outcomes. Each arm represents one of the four possible treatment locations where either the TENS device or the placebo will be applied: upper right, upper left, lower right, and lower left.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Bianchi, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573996
- Sponsor's protocol ID
- IRB2024-212
- Status last verified
- Feb 2026
- First submitted
- 20 Aug 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) is currently under consideration. The primary concerns include ensuring the privacy and confidentiality of participant data, as well as adhering to ethical guidelines and institutional policies. Additionally, the research team is evaluating the feasibility of de-identifying the data in a manner that protects participant identities while still providing valuable insights for future research. A final decision will be made based on these considerations, and the plan will be updated accordingly.
Publications
Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
PubMed 2750720Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.
PubMed 17488999Inauen DS, Papadopoulou AK, Eliades T, Papageorgiou SN. Pain profile during orthodontic levelling and alignment with fixed appliances reported in randomized trials: a systematic review with meta-analyses. Clin Oral Investig. 2023 May;27(5):1851-1868. doi: 10.1007/s00784-023-04931-5. Epub 2023 Mar 6.
PubMed 36879148Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
PubMed 9844209Brown DF, Moerenhout RG. The pain experience and psychological adjustment to orthodontic treatment of preadolescents, adolescents, and adults. Am J Orthod Dentofacial Orthop. 1991 Oct;100(4):349-56. doi: 10.1016/0889-5406(91)70073-6.
PubMed 1927986Roth PM, Thrash WJ. Effect of transcutaneous electrical nerve stimulation for controlling pain associated with orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1986 Aug;90(2):132-8. doi: 10.1016/0889-5406(86)90045-4.
PubMed 3488674Baghdadi ZD. Evaluation of electronic dental anesthesia in children. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Oct;88(4):418-23. doi: 10.1016/s1079-2104(99)70055-7.
PubMed 10519748teDuits E, Goepferd S, Donly K, Pinkham J, Jakobsen J. The effectiveness of electronic dental anesthesia in children. Pediatr Dent. 1993 May-Jun;15(3):191-6.
PubMed 8378157Oztas N, Olmez A, Yel B. Clinical evaluation of transcutaneous electronic nerve stimulation for pain control during tooth preparation. Quintessence Int. 1997 Sep;28(9):603-8.
PubMed 9477875Haralambidis C. Pain-Free Orthodontic Treatment with the Dental Pain Eraser. J Clin Orthod. 2019 Apr;53(4):234-242. No abstract available.
PubMed 31390610Celebi F, Turk T, Bicakci AA. Effects of low-level laser therapy and mechanical vibration on orthodontic pain caused by initial archwire. Am J Orthod Dentofacial Orthop. 2019 Jul;156(1):87-93. doi: 10.1016/j.ajodo.2018.08.021.
PubMed 31256846
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06573996
- Acronym / sponsor ID
- IRB2024-212
- Conditions
- Orthodontic Appliance, Pain, Transcutaneous Electric Nerve Stimulation, Orthodontic Appliance Complication
- Keywords
- Orthodontic Pain, TENS Therapy, Orthodontic Alignment, Randomized Clinical Trial, Transcutaneous Electrical Nerve Stimulation (TENS), Dental Pain Eraser
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 27 Aug 2024 (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 determine whether an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device can reduce pain during orthodontic alignment and leveling in adolescents and adults. The study aims to compare the effectiveness of the TENS device in reducing pain on one side of the mouth, where the device is used, to the other side, where a non-functioning (placebo) device is applied.
The primary questions this study aims to answer are:
Does the TENS device effectively reduce pain during orthodontic treatment compared to the placebo? How do patients pain levels differ between the treated and untreated sides of the mouth?
Participants will:
Have an orthodontic appliance placed on their teeth. Experience the TENS device being applied to one side of their mouth for 2.5 minutes immediately after the appliance placement (brackets and wires).
Report their pain levels at various intervals after the procedure (immediately, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours).
This study includes up to 150 participants who are undergoing routine orthodontic treatment. The findings will help researchers understand whether the TENS device can effectively reduce discomfort during orthodontic procedures, potentially leading to better patient care and comfort.
Detailed description
This randomized, triple-blind, split-mouth clinical trial investigates the efficacy of an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device in reducing pain during orthodontic alignment and leveling. The TENS device, specifically the Dental Pain Eraser (DPE), is designed to modulate nerve activity through neuromodulation, offering a non-pharmacologic method of pain relief.
Participants in the study will undergo standard orthodontic treatment involving the placement of full fixed appliances. Immediately after placing these appliances, the TENS device will be applied to the gums on one side of the mouth for 2.5 minutes, while a placebo device (non-functioning) will be applied to the other side. The assignment of sides will be randomized to minimize bias.
Study Design:
This study is a randomized, quadruple-blind, split-mouth clinical trial designed to evaluate the effectiveness of the intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device, the Dental Pain Eraser (DPE), in reducing pain during orthodontic alignment and leveling. The trial will involve up to 150 participants, both adolescents and adults, undergoing routine orthodontic treatment.
Blinding:
The study is quadruple-blind, meaning that the investigator, participants, the clinicians applying the treatment, and the researchers analyzing the data will be unaware of which side of the mouth received the functioning TENS device versus the placebo. This blinding is critical to eliminating bias in the treatment, assessment, and analysis phases of the study.
Randomization:
Participants will be randomized to receive the TENS device on either the left or right side of their mouth, with the opposite side receiving a placebo (non-functioning) device. Randomization will be conducted using a computer-generated sequence to ensure an equal allocation of treatment across the study population.
Intervention:
TENS Device Application: The TENS device will be applied to the gums on one side of the mouth for 2.5 minutes immediately after the placement of full fixed orthodontic appliances.
Placebo Application: A placebo device that mimics the appearance and application of the TENS device but does not deliver electrical stimulation will be applied to the opposite side of the mouth for the same duration.
Pain Assessment:
Pain levels will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). Assessments will be conducted at the following time points:
Immediately after appliance placement (0 hours) 2 hours post-placement 6 hours post-placement 12 hours post-placement 24 hours post-placement 48 hours post-placement 72 hours post-placement Participants will self-report their pain levels through a standardized survey administered via Google Forms. The survey will be designed to capture both the intensity and duration of pain experienced on each side of the mouth.
Data Collection and Management:
Data will be collected electronically and stored securely with password protection. Each participant's data will be de-identified, and only authorized research personnel will have access to the raw data. Pain ratings will be compiled into a spreadsheet for analysis, with data entry monitored to ensure accuracy.
Statistical Analysis:
The primary analysis will compare the pain levels between the side treated with the functioning TENS device and the placebo side. Paired t-tests will be used to assess the significance of any differences in pain levels. Secondary analyses may include subgroup analyses based on age, gender, and other demographic factors. The level of significance will be set at 0.05.
Detailed Description:
This randomized, triple-blind, split-mouth clinical trial investigates the efficacy of the Dental Pain Eraser (DPE), an intraoral Transcutaneous Electrical Nerve Stimulation (TENS) device, in reducing pain associated with orthodontic alignment and leveling. The DPE device is designed to provide a non-pharmacologic method of pain relief by modulating nerve activity through neuromodulation.
The trial involves up to 150 participants, including adolescents and adults, who are undergoing routine orthodontic treatment with full fixed appliances. The study's split-mouth design allows for intra-subject comparisons, enabling a direct assessment of the TENS device's effectiveness in pain management.
Participants will be randomly assigned to receive the TENS device on one side of their mouth, with the opposite side receiving a placebo device. Both the TENS and placebo devices will be applied for 2.5 minutes immediately after the placement of orthodontic appliances. The study is quadruple-blind, ensuring that neither the investigator, participants, clinicians, nor statisticians know which side received the active treatment.
Pain levels will be measured using a Numeric Rating Scale (NRS) at multiple time points following the orthodontic procedure. The primary outcome measure is the difference in pain levels between the treated and untreated sides of the mouth. Data will be collected via electronic surveys and analyzed using paired t-tests to determine the significance of any differences observed.
The results of this trial are expected to provide valuable insights into non-pharmacologic pain management strategies in orthodontics, potentially leading to improved patient outcomes and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study employs a split-mouth, parallel design, where each participant serves as their own control. The active treatment (TENS device) is applied to one side of the mouth, while a placebo (non-functioning device) is applied to the other side, both during the same session. The allocation of sides (left or right) for the active treatment versus placebo is randomized. This design allows for direct intra-subject comparison of pain levels between the treated and untreated sides, minimizing variability in pain perception and enhancing the reliability of the study outcomes. Each arm represents one of the four possible treatment locations where either the TENS device or the placebo will be applied: upper right, upper left, lower right, and lower left.
| Arm | Type | Receives |
|---|---|---|
| Upper Right Side - Active TENS Device | Experimental | Device: Active TENS DeviceParticipants will receive the active TENS device on the upper right side of their mouth. This arm is designed to evaluate the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the upper arch. |
| Arm 2: Upper Left Side - Placebo/Sham Device | Sham comparator | Device: Intervention 2: Placebo/Sham DeviceParticipants will receive a placebo (non-functioning) device on the upper left side of their mouth. This arm serves as a control to compare pain levels with the side receiving the active TENS device. |
| Arm 3: Lower Right Side - Active TENS Device | Experimental | Device: Active TENS DeviceParticipants will receive the active TENS device on the lower right side of their mouth. This arm is intended to assess the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the lower arch. |
| Arm 4: Lower Left Side - Placebo/Sham Device | Sham comparator | Device: Intervention 2: Placebo/Sham DeviceParticipants will receive a placebo (non-functioning) device on the lower left side of their mouth. This arm also serves as a control, providing a basis for comparison with the side receiving the active TENS device. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- General Health: Patients who are generally healthy.
- Orthodontic Treatment: Patients undergoing orthodontic treatment that requires the use of full-fixed appliances.
- No Pain Medication: Patients not currently taking any medications for pain management.
Key exclusion criteria (3 listed)
- Patients with a history of seizures
- Patients with or with a history of cardiac arrhythmias or pacemaker treatment
- Patients taking any over-the-counter or prescription pain medication during the testing period.
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 |
|---|---|---|
| Active TENS DeviceDescription: The active TENS device, specifically the Dental Pain Eraser (DPE), is applied to the gums for about 2.5 minutes. This intervention is designed to modulate nerve activity to reduce pain during orthodontic alignment and leveling. Arms Associated: Arm 1: Upper Right Side - Active TENS Device Arm 3: Lower Right Side - Active TENS Device | Device | Arm 3: Lower Right Side - Active TENS Device, Upper Right Side - Active TENS Device |
| Intervention 2: Placebo/Sham DeviceThe placebo/sham device is identical in appearance to the TENS device but does not deliver electrical stimulation. It is applied to the gums for 2.5 minutes to serve as a control. Arms Associated: Arm 2: Upper Left Side - Placebo/Sham Device Arm 4: Lower Left Side - Placebo/Sham Device | Device | Arm 2: Upper Left Side - Placebo/Sham Device, Arm 4: Lower Left Side - Placebo/Sham Device |
Primary outcome
Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo
Time frame: Pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement.
The primary outcome measure is the difference in pain levels between the side of the mouth treated with the active TENS device and the side treated with the placebo device. Pain levels will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
1 secondary outcome
Duration of Pain Relief
Time frame: Continuously measured from the time of appliance placement up to 72 hours post-placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 2750720Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
- Background: PubMed 17488999Krishnan V. Orthodontic pain: from causes to management--a review. Eur J Orthod. 2007 Apr;29(2):170-9. doi: 10.1093/ejo/cjl081.
- Background: PubMed 36879148Inauen DS, Papadopoulou AK, Eliades T, Papageorgiou SN. Pain profile during orthodontic levelling and alignment with fixed appliances reported in randomized trials: a systematic review with meta-analyses. Clin Oral Investig. 2023 May;27(5):1851-1868. doi: 10.1007/s00784-023-04931-5. Epub 2023 Mar 6.
- Background: PubMed 9844209Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
- Background: PubMed 1927986Brown DF, Moerenhout RG. The pain experience and psychological adjustment to orthodontic treatment of preadolescents, adolescents, and adults. Am J Orthod Dentofacial Orthop. 1991 Oct;100(4):349-56. doi: 10.1016/0889-5406(91)70073-6.
- Background: PubMed 3488674Roth PM, Thrash WJ. Effect of transcutaneous electrical nerve stimulation for controlling pain associated with orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1986 Aug;90(2):132-8. doi: 10.1016/0889-5406(86)90045-4.
- Background: PubMed 10519748Baghdadi ZD. Evaluation of electronic dental anesthesia in children. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Oct;88(4):418-23. doi: 10.1016/s1079-2104(99)70055-7.
- Background: PubMed 8378157teDuits E, Goepferd S, Donly K, Pinkham J, Jakobsen J. The effectiveness of electronic dental anesthesia in children. Pediatr Dent. 1993 May-Jun;15(3):191-6.
- Background: PubMed 9477875Oztas N, Olmez A, Yel B. Clinical evaluation of transcutaneous electronic nerve stimulation for pain control during tooth preparation. Quintessence Int. 1997 Sep;28(9):603-8.
- Background: PubMed 31390610Haralambidis C. Pain-Free Orthodontic Treatment with the Dental Pain Eraser. J Clin Orthod. 2019 Apr;53(4):234-242. No abstract available.
- Background: PubMed 31256846Celebi F, Turk T, Bicakci AA. Effects of low-level laser therapy and mechanical vibration on orthodontic pain caused by initial archwire. Am J Orthod Dentofacial Orthop. 2019 Jul;156(1):87-93. doi: 10.1016/j.ajodo.2018.08.021.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) is currently under consideration. The primary concerns include ensuring the privacy and confidentiality of participant data, as well as adhering to ethical guidelines and institutional policies. Additionally, the research team is evaluating the feasibility of de-identifying the data in a manner that protects participant identities while still providing valuable insights for future research. A final decision will be made based on these considerations, and the plan will be updated accordingly.
Related trials for Orthodontic Appliance
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Active, not recruitingObservational study
Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners
Malocclusion, Periodontal Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active TENS Device in people with Orthodontic Appliance and Pain, run by University of the Pacific at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Feb 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 States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Bianchi, DDS, msc, phD (4159296556, jbianchi@pacific.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo (time frame: Pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06573996, which also lists 11 linked publications.
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 17 Feb 2026.