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Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel

In-Office Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel: a Randomized, Controlled, Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02414464
Enrollment
53
Registered
2015-04-10
Start date
2013-02-28
Completion date
2015-05-31
Last updated
2018-05-02

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

Conditions

Tooth Discoloration

Keywords

tooth bleaching, adolescent, clinical trial

Brief summary

The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.

Detailed description

A randomized, controlled, clinical trial was conducted with 53 patients aged 11 to 24 years who were allocated to groups based on the use of the following commercial products: Whiteness HP - FGM® (35% hydrogen peroxide); Whiteness HP Blue Calcium - FGM® (35% hydrogen peroxide); and Whiteness HP Blue Calcium - FGM® (20% hydrogen peroxide). After the bleaching procedure, the visual analog scale was used to measure tooth sensitivity and the classic Vita® scale was used to determine changes in tooth color. Statistical analysis involved the Friedman, Kruskal-Wallis and Student-Newman-Keuls tests, with p-value ≤ 0.05 or ≤ 0.0001 considered indicative of statistical significance.

Interventions

Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP 35% gel was applied to the vestibular faces of these teeth. In the present study, the Whiteness HP 35% gel was applied without an external auxiliary source. As this is not a self-catalyzed system, the gel was removed after each 15-minute application and reapplied two more times, totaling 45 minutes of contact with the teeth.

OTHER20% hydrogen peroxide

Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 20% gel was applied to the vestibular faces of these teeth 50 minutes in each session.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* Individuals aged 11 to 24 years with a diagnosis of tooth discoloration and a signed statement of informed consent.

Exclusion criteria

* Individuals with dentofacial anomalies, those without the permanent dentition complete to the second molars, those in orthodontic or orthopedic treatment of the jaws, those who took medications that could alter tooth color and those who had previously been submitted to tooth bleaching

Design outcomes

Primary

MeasureTime frameDescription
DiscolorationChange of teeth color after 48 hours, after 6 months, after 12 months, after 18 monthsthe initial tooth color was determined with the aid of the classic Vita® scale. Tooth color was recorded 48 hours after each session to determine the difference in tone before and after the procedures. It will be carried out in all groups at the following times: pre-treatment period, 48 hours following each session, after six months, after 12 months, after 18 months.

Secondary

MeasureTime frameDescription
Dental sensitivitySensivity alteration up to 48 hours after the procedureThe visual analog scale was used for the subjective measure of sensitivity during and after the procedures.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026