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Gingival irritation during of in-office dental bleaching in adolescents with and without gingival barrier

Gingival irritation during of in-office dental bleaching in adolescents using 6% hydrogen peroxide with and without gingival barrier: randomized double-blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8q6mfhc
Enrollment
Unknown
Registered
2021-09-29
Start date
2021-08-30
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

Tooth discoloration

Interventions

It will be a double-blind split-mouth study. 60 patients will be allocated, through a simple randomization, according to the use or not of gingival barrier. One hemi-arch will receive the gingival bar
E06.420.750

Sponsors

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

Eligibility

Age
12 Years to 14 Years

Inclusion criteria

Inclusion criteria: Age between 12 and 14 years old; good general and oral health; healthy vital teeth; minimum color A2; their guardians 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 gum irritation. Data collected immediately after the bleaching session, up to 1h after, up to 24h after and up to 48h after the procedure, in each session, using the VAS scale (0-10). Percentage of patients with irritation will be called absolute risk of gingival irritation.

Secondary

MeasureTime frame
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 gingival irritation will be evaluated through the records made by the patients using the visual analogue scale VAS (0-10). Values will be presented as mean and standard deviation.;The impact of oral condition on quality of life will be assessed through the Brazilian version of the short form of the Oral Health Impact Profile (OHIP-14), which contains 14 questions, before and after the end of the whitening procedure. 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)