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Effectiveness and safety of at-home tooth Whitening: a clinical study

Efficacy and safety of DSP Home Tooth Whitening: A prospective, single-Blind, randomized study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-8cq89mp
Enrollment
Unknown
Registered
2025-09-29
Start date
2025-09-30
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 prospective, randomized, single-blind study (masked evaluator), which will be carried out at the Dental Clinics of UEPG (State University of Ponta Grossa). Patients will be recruited through
Group 2: 16% carbamide peroxide, 2 hours a day for 21 days
Group 3: 22% carbamide peroxide, 2 hours a day for 21 days. Group 4: 2% desensitizer for 10 minutes before bleaching, application of 10% carbamide peroxide, 2 hours a day for 21 days. Group 5: 2% dese

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Programa de Pós Graduação em Odontologia da Universidade Estadual de Ponta Grossa
Collaborator
Centro de Odontologia Digital
Collaborator
DSP Biomedical
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both sexes; aged 18 years or older; in good general and oral health; absence of carious lesions, restorations, and endodontic treatment in at least the six maxillary anterior teeth; right and left maxillary canines with shade A2 or darker, assessed by comparison with a value-oriented shade guide

Exclusion criteria

Exclusion criteria: Patients with dental prostheses; orthodontic appliances; pregnant or breastfeeding women; smokers; participants with a history of tooth whitening procedures; individuals with bruxism; gingival recession; dentin exposure; visible cracks in the teeth; history of dentin hypersensitivity; users of anti-inflammatory medications

Design outcomes

Primary

MeasureTime frame
All concentrations of carbamide peroxide (10%, 16% and 22%) are expected to provide satisfactory tooth whitening, with a significant improvement in tooth color (?E =3.0) and high patient satisfaction (OES scores =7/10). It is anticipated that prior use of the 2% desensitizer will effectively reduce the occurrence and intensity of dentin sensitivity during and after treatment. The results should prove the safety of the protocols, with a low incidence of adverse effects, maintaining whitening efficacy at all concentrations tested, thus offering safe and reliable alternatives for different clinical needs.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactCleyson Crovador

Universidade Estadual de Ponta Grossa

cleysoncrovador@gmail.com+55(42)999317557

Outcome results

None listed

Source: REBEC (via WHO ICTRP)