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Evaluation of application protocol for at-home bleaching with 4% Hydrogen Peroxide

Evaluation of application protocol of the 4% Hydrogen Peroxide for at-home bleaching - a randomized double-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5n32n5
Enrollment
Unknown
Registered
2019-09-30
Start date
2019-06-03
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

Upper arch alginate impressions will be made from 84 participants of this study. After disinfection, these impressions will be cast with dental plaster. A 1mm flexible vinyl material will be used to m
Other

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: At least 18 years old; good general and oral health; absence of caries and restorations in the anterior superior teeth; upper canines showing color A2 or darker according to color scale Vita Classical (Vita Zahnfabrik, Bad Säckingen, Germany).

Exclusion criteria

Exclusion criteria: Use of dental prosthesis or orthodontic appliances; have deep dental stains (tetracycline and fluorosis stains); pregnant or lactating women; volunteers with any other pathology that may cause sensitivity (such as recession, dentin exposure or the presence of visible cracks in the teeth); parafunctional habits, volunteers who have already undergone tooth whitening procedures or who have previous spontaneous hypersensitivity; to make continuous use of medications that may alter pain perception (painkillers and anti-inflammatory drugs).

Design outcomes

Primary

MeasureTime frame
Expected outcome: Number of patients reporting pain after bleaching agent treatment through self-report. This number will be transformed into percentage of patients with pain and will be called absolute risk of dental sensitivity after bleaching with 4% hydrogen peroxide.;The intensity of dental sensitivity will be evaluated using a 5-point numerical rating scale (NRS 0-4) and visual analog scale (VAS 0-10) and will be presented as mean and standard deviation for 21 days of treatment.

Secondary

MeasureTime frame
The teeth shade of each participant at the beginning of the study, during treatment (after the first, second and third weeks of bleaching treatment) and one month after the whitening will be recorded through subjective and objective evaluation. For subjective evaluation of color, two color guides will be used: Vita Classical (Vita Zahnfabrik) and Vita Bleachedguide 3D-MASTER (Vita Zahnfabrik). For objective color evaluation, a spectrophotometer (Easyshade, Vita Zahnfabrik) will be used.;At the beginning and end of the study, questionnaires will be applied to assess aesthetic self-perception - PIDAQ Psicossocial Impact of Dental Aesthetics Questionnarie).

Countries

Brazil

Contacts

Public ContactAlessandra Reis

Universidade Estadual de Ponta Grossa

reis_ale@hotmail.com+554232203740

Outcome results

None listed

Source: REBEC (via WHO ICTRP)