Skip to content

Evaluation of gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray

Evaluation of gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: randomized single-blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2s34685
Enrollment
Unknown
Registered
2021-04-09
Start date
2021-01-07
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 discoloration

Interventions

It will be a blind mouth-divided study. 120 patients will be allocated, through simple randomization, according to the cutout of the individualized tray. One hemi-arch will receive the cut outlining t
E06.420.750

Sponsors

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

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years; good general and oral health; vital healthy teeth; minimum color A2; agree and sign the informed consent form (TCLE).

Exclusion criteria

Exclusion criteria: Whitening procedure previously; previous dental sensitivity; dental prosthesis; fixed orthodontic appliance; restorations in the anterior superior teeth; endodontic treatment on anterosuperior teeth; gingival recessions; teeth stained by tetracycline or fluorosis; visible cracks in the teeth; continuous use of medications; pregnant or lactating women; bruxism; smokers.

Design outcomes

Primary

MeasureTime frame
Absolute risk of gingival irritation. Data collected during 14 days using the VAS scale (0-10). Percentage of patients with irritation will be called the absolute risk of gingival irritation.

Secondary

MeasureTime frame
Number of patients who report spontaneous pain at any time during 14 days, using the VAS visual analog scale (0-10). Percentage of patients with pain will be called the absolute risk of dental sensitivity.;The difference in color between the baseline condition and 1 month post-bleaching will be assessed by Vita Classical and Bleachedguide Vita shade guide as well as with the Vita Easyshade spectrophotometer. Data will be presented as means an standard deviations.;The intensity of dental sensitivity will be assessed through the records made by patients using the VAS visual analog scale (0-10). Values ??will be presented as mean and standard deviation.;The intensity of gingival irritation will be assessed through the records made by the patients using the VAS visual analog scale (0-10). Values ??will be presented as mean and standard deviation.

Countries

Brazil

Contacts

Public ContactTaynara Carneiro
sctaynara@hotmail.com+55 42 999731515

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 19, 2026