Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06573996
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation TENS on Pain Perception During Orthodontic Alignment and Leveling a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 25 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
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 25 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 25 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 25 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 participants 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 005
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 studys split-mouth design allows for intra-subject comparisons enabling a direct assessment of the TENS devices 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 25 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
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 25 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 25 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 participants 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 005
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 studys split-mouth design allows for intra-subject comparisons enabling a direct assessment of the TENS devices 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 25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None