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Patient satisfaction during Home Whitening using clear aligners: a Blinded Randomized Equivalence Clinical Trial

Patient satisfaction during Home Whitening using clear aligners: a Blinded Randomized Equivalence Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5ykqbcn
Enrollment
Unknown
Registered
2025-08-13
Start date
2024-11-01
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

Dentin sensitivity

Interventions

This is a randomized, blind clinical trial that will clinically evaluate patient satisfaction during at-home bleaching, as well as tooth sensitivity, gingival irritation, and whitening efficacy using
E06.420.750

Sponsors

Andres Felipe felipe Millan Cardenas
Lead Sponsor
Universidade CEUMA
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers of both genders; aged 18 years or older; in good general and oral health; with orthodontic needs or current users of orthodontic aligners; teeth free of carious lesions; no gingival recession or periodontal disease in the anterior region; willing to sign the informed consent form (ICF); tooth color of A2 or darker according to the Vita Classical shade guide on the canines.

Exclusion criteria

Exclusion criteria: Individuals who have previously undergone tooth whitening procedures; history of dental sensitivity; presence of deciduous teeth; use of dental prostheses; restorations on anterior maxillary teeth; previous endodontic treatment on anterior maxillary teeth; presence of gingival recessions; teeth with discoloration due to tetracycline or fluorosis; visible cracks in anterior teeth; continuous use of medications such as analgesics and/or anti-inflammatory drugs; pregnant or breastfeeding women; individuals with parafunctional habits such as bruxism; current smokers

Design outcomes

Primary

MeasureTime frame
Evaluate patient satisfaction resulting from at-home bleaching, using the Visual Analogue Scale (VAS)

Secondary

MeasureTime frame
Evaluate the absolute risk and intensity of tooth sensitivity using the Visual Analogue Scale (VAS);To evaluate the absolute risk and intensity of gingival irritation using the Visual Analogue Scale (VAS);To assess whether there is a difference in the effectiveness of color change, using the Vita Classical scale, Vita Bleachedguide, and the Vita Easyshade spectrophotometer (?WI, ?Eab, ?E00)

Countries

Brazil

Contacts

Public ContactFabiana de Siqueira

Universidade CEUMA

fabisfsiqueira@hotmail.com+55(98)985028509

Outcome results

None listed

Source: REBEC (via WHO ICTRP)