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At-home Bleaching with 5% versus 10% Carbamide Peroxide: a randomized, split-mouth, triple-blind, non-inferiority controlled trial

Comparison of bleaching efficacy of 5% vs. 10% Carbamide Peroxide: a randomized, split-mouth, triple-blind, non-inferiority controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-58gw8gg
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-06-01
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

Tooth Diseases

Interventions

This triple-blind, split-mouth randomized clinical trial aims to clinically evaluate the bleaching efficacy in participants undergoing at-home bleaching with 5% and 10% carbamide peroxide, based on si
D01.339.431.374.424

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients must be 18 years or older. Both sexes. Being in good general and oral health. With no carious lesions, restorations, or endodontic treatment in the maxillary anterior teeth. The maxillary canines must have a shade of A2 or darker according to the value-oriented Vita Classical shade guide (Vita Zahnfabrik, Bad Säckingen, Germany)

Exclusion criteria

Exclusion criteria: Patients already undergoing tooth whitening; undergoing orthodontic treatment; with severe discoloration due to tetracycline stains and fluorosis; participants with any other pathology that could cause sensitivity (such as recession, exposed dentin or presence of visible fissures in the teeth) or history of hypersensitivity; pregnant and lactating women; patients with dental bruxism; taking analgesics or anti-inflammatories

Design outcomes

Primary

MeasureTime frame
To evaluate whether the bleaching efficacy of 5% carbamide peroxide gel is non-inferior to that of 10% carbamide peroxide gel in terms of CIELAB, CIEDE2000 and Whiteness Index for Dentistry using a digital spectrophotometer, and difference in Shade Guide Units using shade guides, through a randomized, triple-blind clinical trial—

Secondary

MeasureTime frame
To evaluate the risk and intensity of tooth sensitivity and gingival irritation using the 0-10 visual analogue scale, as well as the overall patient satisfaction using the Orofacial Esthetic Scale in patients undergoing bleaching with 5% and 10% carbamide peroxide—

Countries

Brazil

Contacts

Public ContactAlessandra Reis

Universidade Estadual de Ponta Grossa

propespsecretaria@uepg.br+55 (42) 3220-3282

Outcome results

None listed

Source: REBEC (via WHO ICTRP)