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Color changes and wear of clear orthodontic aligners after use in the mouth

Color and surface changes of direct printed and thermoformed orthodontic aligners after intraoral aging: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-68c4483
Enrollment
30
Registered
2026-05-27
Start date
2025-09-20
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Color Orthodontic Appliances, Removable

Interventions

This is a randomized clinical trial with three parallel arms. The sample will consist of 30 participants, allocated into three groups (n=10 per group). Participant allocation will be performed using b

Sponsors

Faculdades Integradas Brasil Amazônia
Lead Sponsor
Faculdades Integradas Brasil Amazônia
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals with permanent dentition; no need for extractions as part of the orthodontic treatment plan; Class I or ½ Class II or III malocclusion classified as mild to moderate according to the American Board of Orthodontics (ABO) index; age 18 years or older; both sexes

Exclusion criteria

Exclusion criteria: Participants requiring orthognathic surgery; with periodontal involvement; with craniofacial anomalies or syndromes; with crowding greater than 7 mm; with skeletal posterior crossbite or overjet greater than 5 mm

Design outcomes

Primary

MeasureTime frame
An increase in aligner staining is expected after intraoral use, verified using a visual analog scale, based on the comparison of mean scores before and after use.

Secondary

MeasureTime frame
Surface morphological changes are expected after intraoral use, verified using scanning electron microscopy, based on the qualitative assessment of surface alterations.;An increase in plaque index and exposure to chromogenic substances is expected during treatment, verified using clinical index scores and patient-reported data, based on values recorded during follow-up.

Countries

BR

Contacts

Public ContactMaria Meira

Universidade Federal do Pará

maria.meira@ics.ufpa.br+55(91)3201-7390

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026