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An in vivo study assessing microplastics released in saliva of patients undergoing clear aligner therapy and their Histochemical effects in terms of estrogenicity, cytotoxicity and oxidative stress

Assessment of Histochemical Effects of Microplastics Released during Clear Aligner Therapy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/03/082830
Enrollment
23
Registered
2025-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil Control Intervention1: Clear aligner therapy: Saliva of Participants who are willing to undergo clear aligner therapy, will be assessed for Microplastics(FTIR) and their effect

Sponsors

AB Shetty Memorial Institute of Dental Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Individuals opting for clear aligner therapy 2) Individuals between 18 years to 24 years of age 3) No previous history of orthodontic treatment 4) Individuals willing to participate in the study

Exclusion criteria

Exclusion criteria: 1) Individuals who use tobacco in any form 2) Individuals on medications for systemic conditions 3) Individuals under hormonal replacement therapy 4) Individuals with craniofacial syndromes 5) Individuals with poor oral hygiene 6) Individuals with poor periodontal conditions

Design outcomes

Primary

MeasureTime frame
Microplastics will be assessed using Fourier Transform Infrared spectroscopy The sample will then be tested with:- 1) MTT Assay/ 3-(4,5- dimethylthiazol-2-yl)-2,5-Diphenyl Tetrazolium bromide assay: To evaluate the cytotoxicity of microplastics on primary cultures of human gingival fibroblasts. 2) MCF-7 cell line test: To assess estrogenicity of microplastics. 3) MPO Assay: To assess whether microplastics cause oxidative stress.Timepoint: T0 : control (before onset of treatment) T1: 1 day after onset of treatment T2 : 14 days after onset of treatment T3: 30 days after onset of treatment

Secondary

MeasureTime frame
The results of this study will emphasize the necessity of adopting sustainable practices. The study aligns with the following Sustainable Development Goals i.e. SDG 3 Good health & well being SDG12 Responsible consumption & productionTimepoint: The outcomes will be assessed at 12 months post start of study

Countries

India

Contacts

Public ContactDr Reuben Bensy Thomas

AB Shetty Memorial Institute of Dental Sciences

drcrystalsoans@gmail.com96112 00050

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026