Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05615688
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2022-08-19
Brief Title:
Pain and Activity Levels After Orthodontic Separators
Sponsor:
Lina Sharab
Organization:
University of Kentucky
Study Overview
Official Title:
Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 18-49 in relation to their recorded physical activity level
Hypothesis 1 The investigators hypothesize that participants with higher daily step counts and physical activity levels will report significantly less pain intensity from orthodontic separators than their less active peers following separator placement Null hypothesis is that participants with higher daily step counts will report the same pain intensity from orthodontic separators than their less active peers following separator placement
The secondary aim is to describe the course of pain at 24 hr intervals over the next seven days following separator placement
Hypothesis 2 The investigators hypothesize that more physically active participants will report ratings of zero pain intensity faster sooner than their less active peers throughout the one week study Secondary null hypothesis is that more physically active participants will report ratings of zero pain intensity at the same rate as their less active peers throughout the one week study
Hypothesis 1 The investigators hypothesize that participants with higher daily step counts and physical activity levels will report significantly less pain intensity from orthodontic separators than their less active peers following separator placement Null hypothesis is that participants with higher daily step counts will report the same pain intensity from orthodontic separators than their less active peers following separator placement
The secondary aim is to describe the course of pain at 24 hr intervals over the next seven days following separator placement
Hypothesis 2 The investigators hypothesize that more physically active participants will report ratings of zero pain intensity faster sooner than their less active peers throughout the one week study Secondary null hypothesis is that more physically active participants will report ratings of zero pain intensity at the same rate as their less active peers throughout the one week study
Detailed Description:
Acute pain or discomfort during orthodontic treatment is commonly reported A study done in 2002 found that 87 of patients experienced pain after orthodontic visits Additionally feeling pain has been identified as the primary treatment concern for many patients prior to orthodontic treatment More so it can negatively affect patient compliance and attitude toward treatment
Numerous studies have shown that pain varies in intensity and duration among orthodontic patients The placement of orthodontic separators is a standard procedure to facilitate placement of orthodontic bands by creating a small amount of space between posterior teeth Separator placement reliably produces acute discomfort to patients Pain generated from orthodontic separator placement originates in the periodontal ligament PDL as compression forces are applied to the PDL unequally to open a small space less than 05 mm between the teeth This compression triggers sterile necrosis or hyalinization in some areas of the PDL leading to acute pain The course of pain generated from orthodontic separators typically begins 4 hours after placement reaching highest pain intensity approximately 24 hours after placement and continuing to decrease in intensity until returning to pre-placement baseline after seven days
Variation in reported pain intensity across orthodontic patients is of interest to any practitioner who desires to improve patient outcomes In an attempt to enhance the orthodontist ability to understand pain and its predicting factors researchers have examined pain from orthodontic treatment relative to patient demographics personality traits psychological factors perceived need and attitude toward treatment among others Okeson asserts that pain is not directly related to the extent of tissue injury Noxious stimuli originating in peripheral neurons such is the case with separators are subject to modulation at multiple levels through a complex central inhibitory system where many other factors participate in decreasing or increasing the pain experience Hence an individuals emotional state pain expectation and perception of control as well as activities or distractions that will differ brain attention Gate Control can significantly influence the pain experience Perceived stress or the degree to which situations in an individuals life exceed their ability to cope could be a good predictor of experienced pain The Perceived Stress Scale is the most widely used screening form to evaluate perceived stress and asks subjects to recall the frequency of feeling overloaded and overwhelmed in the past month
Recently more attention has been given to the role of physical activity PA in reducing pain in patients that undergo orthodontic treatment Physical activity has been shown to be an effective mediator of acute pain tolerance and pain sensitivity an effect known as Exercise Induced Hypoalgesia EIH One study reported that a 1-mile run decreased pain intensity evoked from a weight being placed on the index finger A similar decrease in pain response to pressure applied to the finger was found in subjects in another study who performed 30 minutes of aerobic exercise It has also been demonstrated that exercise increased dental pain thresholds in response to electrical stimulation of the pulp The exact mechanism involved in EIH remains elusive Still several pathways have been implicated including activation of the endogenous opioid pathway increased Adrenocorticotropic Hormone release and a conditioned pain the pain perceived in another area of the body
Researchers have demonstrated that higher self-reported physical activity reduced the pain levels generated by placement of orthodontic separators when compared to patients with low physical activity Self-reported measurements of physical activity carry limitations The Physical Activity Questionnaire PAQ used in previous studies have demonstrated an only moderate correlation with direct activity observation r045 and with an activity monitoring device r057 The PAQ asks participants to report pain in the last seven days and if given before treatment was performed provides no data on physical activity during the week when subjects are experiencing pain To further explore the correlation between physical activity and acute pain during orthodontic treatment a more reliable measure of physical activity is warranted
Actigraphy sensors provide an objective measure of physical activity Actigraphy sensors include pedometers which count steps over a defined time interval and accelerometers which measure acceleration in activity counts that are then extrapolated to the Metabolic Equivalent of Task METS to measure energy expenditure No other paper has evaluated the effect of physical activity measured with pedometers on acute pain following separators placement during orthodontic treatment Because not all patients experience pain at the same level it would be beneficial for clinicians to identify which patients are likely to experience more intense pain before beginning treatment To this end the purpose of this study is to test the effect of physical activity measured by pedometer on acute pain produced by the placement of separators
Numerous studies have shown that pain varies in intensity and duration among orthodontic patients The placement of orthodontic separators is a standard procedure to facilitate placement of orthodontic bands by creating a small amount of space between posterior teeth Separator placement reliably produces acute discomfort to patients Pain generated from orthodontic separator placement originates in the periodontal ligament PDL as compression forces are applied to the PDL unequally to open a small space less than 05 mm between the teeth This compression triggers sterile necrosis or hyalinization in some areas of the PDL leading to acute pain The course of pain generated from orthodontic separators typically begins 4 hours after placement reaching highest pain intensity approximately 24 hours after placement and continuing to decrease in intensity until returning to pre-placement baseline after seven days
Variation in reported pain intensity across orthodontic patients is of interest to any practitioner who desires to improve patient outcomes In an attempt to enhance the orthodontist ability to understand pain and its predicting factors researchers have examined pain from orthodontic treatment relative to patient demographics personality traits psychological factors perceived need and attitude toward treatment among others Okeson asserts that pain is not directly related to the extent of tissue injury Noxious stimuli originating in peripheral neurons such is the case with separators are subject to modulation at multiple levels through a complex central inhibitory system where many other factors participate in decreasing or increasing the pain experience Hence an individuals emotional state pain expectation and perception of control as well as activities or distractions that will differ brain attention Gate Control can significantly influence the pain experience Perceived stress or the degree to which situations in an individuals life exceed their ability to cope could be a good predictor of experienced pain The Perceived Stress Scale is the most widely used screening form to evaluate perceived stress and asks subjects to recall the frequency of feeling overloaded and overwhelmed in the past month
Recently more attention has been given to the role of physical activity PA in reducing pain in patients that undergo orthodontic treatment Physical activity has been shown to be an effective mediator of acute pain tolerance and pain sensitivity an effect known as Exercise Induced Hypoalgesia EIH One study reported that a 1-mile run decreased pain intensity evoked from a weight being placed on the index finger A similar decrease in pain response to pressure applied to the finger was found in subjects in another study who performed 30 minutes of aerobic exercise It has also been demonstrated that exercise increased dental pain thresholds in response to electrical stimulation of the pulp The exact mechanism involved in EIH remains elusive Still several pathways have been implicated including activation of the endogenous opioid pathway increased Adrenocorticotropic Hormone release and a conditioned pain the pain perceived in another area of the body
Researchers have demonstrated that higher self-reported physical activity reduced the pain levels generated by placement of orthodontic separators when compared to patients with low physical activity Self-reported measurements of physical activity carry limitations The Physical Activity Questionnaire PAQ used in previous studies have demonstrated an only moderate correlation with direct activity observation r045 and with an activity monitoring device r057 The PAQ asks participants to report pain in the last seven days and if given before treatment was performed provides no data on physical activity during the week when subjects are experiencing pain To further explore the correlation between physical activity and acute pain during orthodontic treatment a more reliable measure of physical activity is warranted
Actigraphy sensors provide an objective measure of physical activity Actigraphy sensors include pedometers which count steps over a defined time interval and accelerometers which measure acceleration in activity counts that are then extrapolated to the Metabolic Equivalent of Task METS to measure energy expenditure No other paper has evaluated the effect of physical activity measured with pedometers on acute pain following separators placement during orthodontic treatment Because not all patients experience pain at the same level it would be beneficial for clinicians to identify which patients are likely to experience more intense pain before beginning treatment To this end the purpose of this study is to test the effect of physical activity measured by pedometer on acute pain produced by the placement of separators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None