Microplastic Exposure From Clear Aligner Wear (MPE)
ConditionMicroplastic Exposure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-75
SponsorUniversity of North Carolina, Chapel Hill
About this trial
An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 75 years
Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy
Stable physical health (ASA I or II), as determined by study coordinator or PI
Able to comprehend and follow requirements of study (including availability on scheduled visit dates)
Disqualifiers
Receiving orthodontic treatment with fixed appliances
Receiving hybrid treatment with fixed appliances and aligners
Receiving Phase I orthodontic treatment with fixed appliances
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
Trial population
The study population includes patients identified from UNC orthodontic clinics who are scheduled (prior to study engagement) to receive clear aligner treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clear Aligner Treatment
Other interventionThis study is observational. Only patients who are previously scheduled to receive clear aligner treatment from their orthodontic provider will be recruited.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Clear Aligner Treatment1 intervention
Trial outcomes
Primary outcomes
1
Change in salivary microplastic abundance over time.
Differences in microplastic abundance in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Time frame
Pre-treatment through 16-24 weeks post-treatment.2
Change in urinary microplastic abundance over time.
Differences in microplastic abundance in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Time frame
Pre-treatment through 16-24 weeks post-treatment.Secondary outcomes
1
Change in salivary microplastic size over time.
Differences in microplastic size in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Time frame
Pre-treatment through 16-24 weeks post-treatment.2
Change in salivary microplastic composition over time.
Differences in microplastic identities in saliva collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Time frame
Pre-treatment through 16-24 weeks post-treatment.3
Change in urinary microplastic size over time.
Differences in microplastic size in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Time frame
Pre-treatment through 16-24 weeks post-treatment.4
Change in urinary microplastic composition over time.
Differences in microplastic identities in urine collected pre-treatment with clear aligners, 6-12 weeks post-treatment, and 16-24 weeks post-treatment.
Time frame
Pre-treatment through 16-24 weeks post-treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov