RECRUITING

Comparison of Patient-reported Pain After Initial Archwire Placement

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

Three different types of 'archwires' can be used in Orthodontic treatment, wire choice is decided by treating Orthodontist based on professional preference since research shows that all types are equally effective. It is possible that one type of wire engenders more patient discomfort. This study will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.

Official Title

Comparison of Patient-reported Pain After Initial Archwire Placement With Three Types of Nickel-titanium Archwires: a Prospective Triple-blind, Randomized Controlled Clinical Trial

Quick Facts

Study Start:2019-05-10
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03906422

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:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Healthy, with no significant systemic diseases or complications or special needs
  2. 2. Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
  3. 3. All banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth).
  4. 4. Any planned dental extractions that is part of the orthodontic treatment plan must be carried out at least 3 weeks prior to or after initial orthodontic appliance bonding.
  5. 5. Age 12 years or older
  1. 1. Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines
  2. 2. Currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period
  3. 3. Metal-type (Nickel) allergies
  4. 4. Less than 12 years old
  5. 5. Same day use of analgesics prior to bonding
  6. 6. Treatment requiring dental extractions prior to or immediately after bonding of fixed appliance

Contacts and Locations

Study Contact

Clifton M Carey, PhD
CONTACT
303-724-1046
clifton.carey@ucdenver.edu
Craig Shellhart, DDS
CONTACT
303-724-6993
craig.shellhart@ucdenver.edu

Study Locations (Sites)

University of Colorado School of Dental Medicine
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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 Date2019-05-10
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2019-05-10
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • Orthodontic
  • Pain

Additional Relevant MeSH Terms

  • Orthodontic Discomfort
  • Pain, Orofacial