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Effect on color change, sensitivity, psychological impact, and social impact of 7.5% at-home bleaching

At home bleaching with 7,5% Hydrogen Peroxide: effectiveness, sensitivity and satisfaction in different application times

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2zx87wv
Enrollment
90
Registered
2026-06-11
Start date
2019-10-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Sensitivity Tooth Bleaching

Interventions

90 volunteers included in the research will be submitted to at home bleaching, using 7,5% Hydrogen Peroxide gel. There will be three intervention groups, with 30 participants each, in A group partici

Sponsors

Universidade Federal do Amazonas
Lead Sponsor
Universidade Federal do Amazonas
Collaborator

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age 18 to 40; two central incisors or canine with a dark tooth coloration; the six upper anterior teeth free of restorations; healthy enamel

Exclusion criteria

Exclusion criteria: Volunteers with orthodontic aplliance; severe crowding; presence of intrinsic stains (tetracycline staining; fluorosis; pulped teeth); under use of anti-inflammatory drugs; smokers; etilists; pregnant or lactating women; people who have already undergone bleaching procedure; participants with bruxism; participants with exposed dentin in the upper anterior teeth; non-carious cervical lesions.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: It is expected to evaluate the bleaching efficacy of 6% hydrogen peroxide gel applied for 15, 30, and 60 minutes daily through tooth color change measured by ?E obtained by spectrophotometry and by changes in the Vita Classical and Vita Bleachedguide shade scales. It is expected that the different application times will present similar bleaching efficacy;Observed outcome 1: Tooth color change was observed in all evaluated groups (PH15, PH30, and PH60), measured by the Whiteness Index for Dentistry (WID), with no statistically significant difference among application times (p=0.3058), indicating similar bleaching efficacy among the protocols

Secondary

MeasureTime frame
Expected outcome 4: It is expected to evaluate the psychosocial impact of dental bleaching using the PIDAQ questionnaire, considering the domains of dental self-confidence, psychological impact, social impact, and aesthetic concern;Observed outcome 4: All groups showed improvement in the PIDAQ domains (dental self-confidence, psychological impact, social impact, and aesthetic concern), with no statistically significant difference among the protocols (p>0.05), indicating a similar positive psychosocial impact among application times;Expected outcome 2: It is expected to evaluate tooth sensitivity associated with bleaching using 6% hydrogen peroxide at different application times through self-report using a 5-point Likert Scale and a Visual Analog Scale, considering sensitivity intensity and absolute risk among groups;Observed outcome 2: Tooth sensitivity was predominantly classified as mild among participants (PH15: 38.71%; PH30: 30.00%; PH60: 31.03%), with no statistically significant difference among groups (p=0.8826), indicating similar behavior among the protocols;Expected outcome 3: It is expected to evaluate the time required for participants to achieve satisfaction with tooth color after bleaching treatment, comparing the different application times;Observed outcome 3: The time required to achieve satisfaction with tooth color was similar among groups (PH15: 16.48 ± 8.19 days; PH30: 17.84 ± 11.41 days; PH60: 18.14 ± 9.19 days), with no statistically significant difference (p=0.510)

Countries

BR

Contacts

Public ContactLaís Mota

Universidade Federal do Amazonas

laisbelem_@hotmail.com+55(92)33054924

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 29, 2026