COMPLETED

Pain and Activity Levels After Orthodontic Separators

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 15-49 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.

Official Title

Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity?

Quick Facts

Study Start:2022-07-14
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05615688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 49 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Student, resident, or staff at the University of Kentucky
  2. * Aged 15-49 at time of enrollment in the study
  3. * Erupted permanent first and second molars with interproximal contacts
  4. * Presence of antagonist teeth in the opposite arch with no open bite
  5. * Voluntary participation in study
  6. * Access to a smartphone, tablet, or computer
  7. * Valid email address
  1. * Any chronic pain condition (examples include trigeminal neuralgia, migraines, fibromyalgia, arthritis, neuropathies)
  2. * Current use of pain medication (analgesics, opioids, nerve pain medications) for any condition
  3. * Clinically evident interproximal decay in the site where separators will be placed
  4. * Missing teeth, variations in tooth anatomy, existing space, and or restorations that would keep separators from being placed or retained
  5. * If you do not have access to a computer, smartphone, or tablet with internet access

Contacts and Locations

Principal Investigator

Lina Sharab, DDS, MS, MSc
PRINCIPAL_INVESTIGATOR
Assistant Professor, Orthodontics

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Lina Sharab

  • Lina Sharab, DDS, MS, MSc, PRINCIPAL_INVESTIGATOR, Assistant Professor, Orthodontics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-14
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2022-07-14
Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Dental Malocclusion