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Evaluation of the Chemical and Mechanical Properties of Invisible Orthodontic Aligners: A Laboratory and Human Study

Evaluation of the chemical and mechanical properties of orthodontic aligners: in vitro and in vivo study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-424gzzy
Enrollment
Unknown
Registered
2024-08-22
Start date
2024-09-16
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Encounter for fitting and adjustment of orthodontic device

Interventions

The research corresponds to a prospective clinical study, single-blind, qualitative and quantitative, in vivo and in vitro, with the aim of evaluating changes in mechanical properties, release of BPA
C25.723

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: Individuals between the ages of 18 and 30; both genders; systemically healthy; with good oral hygiene; with the presence of dental malocclusion; healthy periodontium and absence of dental caries

Exclusion criteria

Exclusion criteria: Individuals under 18 years of age, with serious systemic alterations; using medications that may cause alterations in salivary flow; using antibiotics and anti-inflammatory drugs in the last 03 months; abnormal/non-healthy periodontium and presence of dental caries; individuals with clinical signs of parafunctional habits, free of malocclusion, and who underwent restorations in the last 12 months will be excluded from the study

Design outcomes

Primary

MeasureTime frame
It is expected that a greater release of BPA and phthalates will be identified, statistically relevant decrease in physical properties, and greater biofilm accumulation in thermoformed aligners compared to those made by 3D printing.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactJader Jorge

Universidade Federal de Minas Gerais

jader.oj@gmail.com+55(31)34092405

Outcome results

None listed

Source: REBEC (via WHO ICTRP)