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NCT05615688
Pain and Activity Levels After Orthodontic Separators
Conditions: Dental Malocclusion
Sex: All
Ages: 18 Years – 49 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 94
Sponsor: Lina Sharab
Location: United States
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 placementThe 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.
Eligibility Criteria
Inclusion Criteria:Student, resident, or staff at the University of KentuckyAged 18-49 at time of enrollment in the studyErupted permanent first and second molars with interproximal contactsPresence of antagonist teeth in the opposite arch with no open biteVoluntary participation in studyAccess to a smartphone, tablet, or computerValid email addressExclusion 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 conditionClinically evident interproximal decay in the site where separators will be placedMissing teeth, variations in tooth anatomy, existing space, and or restorations that would keep separators from being placed or retainedIf you do not have access to a computer, smartphone, or tablet with internet access
Source: ClinicalTrials.gov (NCT05615688). StuddyBuddy aggregates publicly available trial information.