Clinical trial NCT05615688: Pain and Activity Levels After Orthodontic Separators
Official title: Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Malocclusion
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Elastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject.

Activity monitors will be provided and participants instructed to wear 24/7 unless showering or swimming to measure and collect level of physical activity

Baseline data will be collected via questionnaires that include: Medical History, Demographics, and Perceived Stress Scale.

Subjects will also complete a Recurrent Questionnaire at 2-4 hrs post placement and every evening for days 2-7 to report Pain Intensity using a Visual Analog Scale
Primary purpose: SUPPORTIVE_CARE

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.

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 0.5 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 individual's 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 individual's 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 (r=0.45), and with an activity monitoring device (r=0.57). 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.

Eligibility criteria: Inclusion Criteria:

* Student, resident, or staff at the University of Kentucky
* Aged 18-49 at time of enrollment in the study
* Erupted permanent first and second molars with interproximal contacts
* Presence of antagonist teeth in the opposite arch with no open bite
* Voluntary participation in study
* Access to a smartphone, tablet, or computer
* Valid email address

Exclusion Criteria:

* Any chronic pain condition (examples include trigeminal neuralgia, migraines, fibromyalgia, arthritis, neuropathies)
* Current use of pain medication (analgesics, opioids, nerve pain medications) for any condition
* Clinically evident interproximal decay in the site where separators will be placed
* Missing teeth, variations in tooth anatomy, existing space, and or restorations that would keep separators from being placed or retained
* If you do not have access to a computer, smartphone, or tablet with internet access

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: 7 days
Secondary outcomes:
measure: Change in Proportion of patients reporting ZERO Pain over time
timeFrame: 7 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: Assistant Professor, Orthodontics
name: Lina Sharab, DDS, MS, MSc
role: PRINCIPAL_INVESTIGATOR
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