Dental Malocclusion Clinical Trial
Official title:
Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity?
NCT number | NCT05615688 |
Other study ID # | 55656 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 14, 2022 |
Est. completion date | May 31, 2024 |
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.
Status | Recruiting |
Enrollment | 94 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Lina Sharab |
United States,
Abu Alhaija ES, Aldaikki A, Al-Omairi MK, Al-Khateeb SN. The relationship between personality traits, pain perception and attitude toward orthodontic treatment. Angle Orthod. 2010 Nov;80(6):1141-9. doi: 10.2319/012710-59.1. — View Citation
Beck VJ, Farella M, Chandler NP, Kieser JA, Thomson WM. Factors associated with pain induced by orthodontic separators. J Oral Rehabil. 2014 Apr;41(4):282-8. doi: 10.1111/joor.12144. Epub 2014 Feb 1. — View Citation
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Sandhu SS, Leckie G. Orthodontic pain trajectories in adolescents: Between-subject and within-subject variability in pain perception. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):491-500.e4. doi: 10.1016/j.ajodo.2015.10.020. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pain Intensity | Subjects will be given an activity monitor to wear full time following the placement of the orthodontic spacers. They will report their level of pain to on a recurrent Pain Intensity questionnaire (using a Visual Analog Scale in REDCap) at 2-4 hrs after placement, and again at 24 hour intervals for the next 7 days following separator placement. The left of the digital Visual Analog Scale will be labeled "no pain" and the right will be labeled "worst pain imaginable". REDCap assigns a value of 0 on the left side of the scale and increased to100 on the right of the scale. | 7 days | |
Secondary | Change in Proportion of patients reporting ZERO Pain over time | Subjects will be given an activity monitor to wear full time following the placement of the orthodontic spacers. They will report their level of pain on a recurrent Pain Intensity questionnaire (using a Visual Analog Scale in REDCap) at 2-4 hrs after placement, and again at 24 hour intervals for the next 7 days following separator placement. The left of the digital Visual Analog Scale will be labeled "no pain" and the right will be labeled "worst pain imaginable". REDCap assigns a value of 0 on the left side of the scale and increased to100 on the right of the scale. | 7 days |
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