Physical Activity Impact on Orthodontic Separator Pain for Dental Misalignment
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you are not currently using any pain medications, such as analgesics, opioids, or nerve pain medications, for any condition.
Is the use of orthodontic separators and related devices generally safe for humans?
How does the treatment of orthodontic separators differ from other treatments for dental misalignment pain?
This treatment is unique because it explores the impact of physical activity on pain perception after placing orthodontic separators, which are small devices used to create space between teeth before braces. Unlike other treatments that might focus solely on pain relief through medication, this study considers how a person's level of physical activity might naturally influence their experience of pain.23567
What is the purpose of this trial?
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.
Research Team
Lina Sharab, DDS, MS, MSc
Principal Investigator
Assistant Professor, Orthodontics
Eligibility Criteria
This trial is for University of Kentucky students, staff, or residents aged 18-49 with misaligned teeth who are not on pain medication and do not have chronic pain conditions. Participants must have a valid email, access to a smart device with internet, and certain dental criteria like erupted molars without decay.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Placement of orthodontic separators and monitoring of pain intensity in relation to physical activity levels
Follow-up
Participants report pain levels at 24-hour intervals for 7 days following separator placement
Treatment Details
Interventions
- Physical Activity Level Monitoring
- Placement of Orthodontic Separators
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lina Sharab
Lead Sponsor