RECRUITING

Microplastic Exposure From Clear Aligner Wear (MPE)

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Conditions

Microplastic Exposure

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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

An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.

Official Title

Microplastic Exposure From Clear Aligner Wear: An In Vivo, Longitudinal Study of Orthodontic Patients

Quick Facts

Study Start:2025-05
Study Completion:2035-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06934603

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:10 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 90 years
  2. * Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy
  3. * Stable physical health (ASA I or II), as determined by study coordinator or PI
  4. * Able to comprehend and follow requirements of study (including availability on scheduled visit dates)
  5. * Patient and parental consent (and assent for minors) for participation in the study
  1. * Receiving orthodontic treatment with fixed appliances
  2. * Receiving hybrid treatment with fixed appliances and aligners
  3. * Receiving Phase I orthodontic treatment with fixed appliances
  4. * Established history of severe xerostomia (dry mouth), severe periodontal disease with actively bleeding gums, significant oral abrasions/ulcers or growths, current alcohol abuse, and/or recreational drug abuse
  5. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with participation
  6. * Drinking, eating, or brushing teeth within 1 hour of study visit
  7. * Removing aligners within 1 hour of study visit
  8. * Developmental or cognitive disability such that the patient cannot self-consent, comprehend, and follow the requirements of the study based on research site personnel's assessment

Contacts and Locations

Study Contact

Laura A Jacox, DMD, PhD, MS
CONTACT
919-537-3424
ljacox@live.unc.edu
S.T. Phillips, BSDH
CONTACT
919-537-3422
sherrill_phillips@unc.edu

Principal Investigator

Laura A Jacox, DMD, PhD, MS
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Laura A Jacox, DMD, PhD, MS, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

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 Date2025-05
Study Completion Date2035-05

Study Record Updates

Study Start Date2025-05
Study Completion Date2035-05

Terms related to this study

Additional Relevant MeSH Terms

  • Microplastic Exposure