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Upper Right Side - Active TENS Device for Orthodontic Braces

N/A
Waitlist Available
Research Sponsored by University of the Pacific
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
General Health: Patients who are generally healthy.
Orthodontic Treatment: Patients undergoing orthodontic treatment that requires the use of full-fixed appliances.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

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. 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 patient's 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 before the appliance placement. 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.

Who is the study for?
This trial is for adolescents and adults who are about to receive orthodontic appliances. Participants must be willing to report their pain levels at multiple times after the procedure. There's no specific mention of exclusion criteria, so general health requirements likely apply.
What is being tested?
The study tests if a TENS device can lessen pain during orthodontic treatment by comparing a working TENS on one side of the mouth with a placebo device on the other side. Each participant serves as their own control, ensuring direct comparison within individuals.
What are the potential side effects?
While not explicitly stated, typical side effects from using TENS may include skin irritation where the pads attach, tingling or prickling sensations during use, and muscle twitching. Most people tolerate it well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo
Secondary study objectives
Duration of Pain Relief

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Upper Right Side - Active TENS DeviceExperimental Treatment1 Intervention
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.
Group II: Arm 3: Lower Right Side - Active TENS DeviceExperimental Treatment1 Intervention
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.
Group III: Arm 4: Lower Left Side - Placebo/Sham DevicePlacebo Group1 Intervention
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.
Group IV: Arm 2: Upper Left Side - Placebo/Sham DevicePlacebo Group1 Intervention
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.

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Who is running the clinical trial?

University of the PacificLead Sponsor
15 Previous Clinical Trials
856 Total Patients Enrolled
~100 spots leftby Sep 2028
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