The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation (TENS) on Pain Perception During Orthodontic Alignment and Leveling: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Upper Right Side - Active TENS Device
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.
干预措施: Active TENS Device (Device)
Arm 2: Upper Left Side - Placebo/Sham Device
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.
干预措施: Intervention 2: Placebo/Sham Device (Device)
Arm 3: Lower Right Side - Active TENS Device
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.
干预措施: Active TENS Device (Device)
Arm 4: Lower Left Side - Placebo/Sham Device
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.
干预措施: Intervention 2: Placebo/Sham Device (Device)
结局指标
主要结局
Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo
时间窗: 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).
次要结局
- Duration of Pain Relief(Continuously measured from the time of appliance placement up to 72 hours post-placement.)
研究者
Jonas Bianchi
Assistant Professor
University of the Pacific