In-Office Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel: a Randomized, Controlled, Clinical Trial
| Registry | NCT02414464 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 53 (Actual) |
| Sponsor | University of Nove de Julho (Other) |
| Conditions | Tooth Discoloration |
| Interventions | 35% hydrogen peroxide, 20% hydrogen peroxide (Other) |
| Dates | start 2013-02-01, primary completion 2014-09-01, completion 2015-05-01, first posted 2015-04-10, last updated 2018-05-02 |
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All trials for Tooth Discoloration All trials of 35% hydrogen peroxide All trials of 20% hydrogen peroxide
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 35% hydrogen peroxide | Experimental | Other: 35% hydrogen peroxide | Volunteers of this group will receive a gel with 35% hydrogen peroxide - Whiteness HP 35% for whitening treatment. |
| 35% hydrogen peroxide with calcium | Experimental | Other: 35% hydrogen peroxide | Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 35% for whitening treatment. |
| 20% hydrogen peroxide with calcium | Experimental | Other: 20% hydrogen peroxide | Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 20% for whitening treatment. |
Sex: All, ages: 11 Years to 24 Years, accepts healthy volunteers
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