Microplastic release from clear orthodontic aligners Cytotoxicity of substances released from clear aligners Particle morphology and chemical composition of detached microplastics Weight loss of clear aligners under simulated intraoral conditions Safety and biocompatibility of clear aligners in healthy adults Clear aligner Microplastic release Cytotoxicity Intraoral aging Biocompatibility
Conditions
Interventions
Used aligner will be obtained from patient who meet the inclusion criteria. All participants who meet the criteria will sign informed consent forms and receive instructions on the modified Bass techni
Basic Science,Basic Science
Used aligner ,Unused aligner
Sponsors
Faculty of Dentistry, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants (for 7-day-used aligners) 1. Individuals aged 18 years or older 2. Good oral hygiene, evaluated using standard indices 3. No history of plastic material allergy or tobacco use 4. Irregularity index < 1 5. Presence of 24-28 permanent teeth 6. Currently undergoing orthodontic treatment with clear aligners from one of the selected brands (Invisalign, Spark, Smartee, or TrioClear) 7. Able to wear aligners for at least 22 hours per day for 7 consecutive days 8. Participants must not be using their first aligner and must have been in active treatment Clear Aligners 1. Unused aligners obtained directly from manufacturers 2. Used aligners must have been worn intraorally by participants for 7 consecutive days in accordance with standard usage protocols 3. Aligners must be from one of the selected brands (Invisalign, Spark, Smartee, or TrioClear) 4. All aligners must be intact, undamaged, and unmodified 5. One upper central incisor on the aligner must be free of any attachments
Exclusion criteria
Exclusion criteria: 1. Participants diagnosed with periodontitis, oral mucosal diseases, or systemic conditions such as diabetes mellitus, HIV infection, genetic disorders, or ongoing malignant disease 2. Participants who fail to follow standard aligner wear instructions (e.g., wearing aligners during meals, improper cleaning methods) 3. Participants with high caries risk or poor oral hygiene as determined by clinical examination 4. Participants with concurrent use of additional orthodontic appliances or auxiliaries that may alter surface wear of the aligners 5. Participants who have oral restorations, prosthetics, tooth whitening, bonding, or repair attachments within 1 month 6. Participants who have prosthetics on upper incisor teeth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount and size of microplastic detachment After 7 days of immersion in artificial saliva Mass of detached microplastics (ug/mL) and particle-size distribution (um) measured using Raman spectroscopy,Cytotoxic effects After 7 days of immersion in Dulbecco's Modified Eagle Medium (DMEM) Percentage of cell vitality measured using MTT cell viability assay (MTT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight loss of clear aligner After 7 days of immersion in artificial saliva Weight (mg), measured using an analytical balance with 4-digit precision | — |
Countries
Thailand
Contacts
Public ContactKotchaporn Jiraritthumrong
Department of Orthodontics, Chulalongkorn University
Outcome results
None listed