Analyzing microplastic release from orthodontic aligners : An In-vivo approach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- The study found that PET, PETG, and PU aligners release
Study Overview
Brief Summary
Clear orthodontic aligners are widely popular due to their aesthetic appeal and functional advantages. However, concerns about the release of microplastics (MPs) from these aligners have emerged, as plastic materials are susceptible to mechanical degradation. Ingesting MPs has been associated with oxidative stress, inflammatory lesions, and other health issues, including disruptions to gut microbiota, respiratory complications, cardiovascular risks, and cognitive function. This study investigates the in-vivo release of MPs from orthodontic aligners made of polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), and polyurethane (PU), with a control group of patients using traditional metal braces.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 35.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with moderate to mild orthodontic malocclusions requiring clear aligner treatment
- •Ability to commit to regular follow-up appointments for the duration of the study.
- •Non-smokers to eliminate potential confounding factors related to oral health and material degradation
- •No known allergies or sensitivities to materials used in orthodontic aligners (PET, PETG, PU).
Exclusion Criteria
- •Patients with severe malocclusions requiring non-clear aligner treatment options such as surgery
- •Patients with a history of allergic reactions to materials used in clear aligners (PET, PETG, PU)
- •Patients with temporomandibular joint disorders (TMD) that may affect aligner wear or exacerbate discomfort during treatment.
Outcomes
Primary Outcomes
The study found that PET, PETG, and PU aligners release
Time Frame: 3 months
microplastics, with varying amounts, while metal braces
Time Frame: 3 months
showed no microplastic release, emphasizing health and
Time Frame: 3 months
sustainability concerns.
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Karthick P
Chettinad Dental College and Research Institute