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.

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.

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.