Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There is a controversy in the dentistry literature about how the use of associated light to activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the bleaching effectiveness. The studies that demonstrated an increased level of bleaching using light activation employed lower hydrogen peroxide gels while the ones reporting no statistical difference employed higher hydrogen peroxide gels.
The hypothesis of this study is that the effectiveness of light activation tooth bleaching in dependent on the hydrogen peroxide concentration employed.
The aim of this study is to compare the color change and tooth sensitivity of in-office bleaching using different hydrogen peroxide concentrations and with or without light activation. Sixty patients will be enrolled in this trial and divide equally into 4 groups according to the combination of the main factors hydrogen peroxide concentration (35% or 20%) or LED/laser activation (yes or no). Three 15-min applications will be performed in each clinical appointment. A LED/laser device will be used in the respective groups for three 1-min application with an interval of 2 min. The same procedure will be repeated one week later. The color change will be assessed after hte 1st and 2nd session, after 1 week and 6 months of the end of the treatment using a value-oriented shade Vita Classical and a spectrophotometer Easy Shade. The tooth sensitivity will be reported by patients using a 0 to 10 visual analog scale. The Student t test (α = .05) will be used to compare the tooth color changes and the intensity of tooth sensitivity between groups at baseline and immediately after the first and second bleaching appointments. The Fisher exact test and Student t test (α = .05), respectively, will be used to analyze the percentage of patients with tooth sensitivity and its intensity.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 35% hydrogen peroxide control | Active Comparator | The tooth bleaching will be performed using a high hydrogen peroxide concentration (35%) without light-activation with LED/light device |
|
| 20% hydrogen peroxide | Active Comparator | The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) without light activation with a LED/laser device |
|
| 35% hydrogen peroxide + light | Experimental | The tooth bleaching will be performed with a high hydrogen peroxide concentration (35%) associated with LED/laser light activation |
|
| 20% hydrogen peroxide + light | Experimental | The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) associated with LED/laser light activation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in-office bleaching with/without light | Procedure | Two clinical sessions of tooth bleaching will be performed in each patient with a 1-week interval between them. In each session, three 15-min applications of the gel will be done using one of the two concentrations under investigation. In half of the sample of each concentration, the gel will be activated with a LED/laser device for a total of 3 min, as specified by the DMC manufacturer. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in color | The change in color will be measured using Vita Shade Classical scale at baseline and after the end of the bleaching protocol. A spectrophootometer Easy Shade will also be used and the coordinates of the CIELab system will be recorded. | at the 2-week recall |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence and intensity of tooth sensitivity | The visual analog scale will be used for patients to record their tooth sensitivity in a 0 to 10 scale. | 24-hours after the bleaching |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandra Reis, DDS, MS | Universidade Estadual de Ponta Grossa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry - Universidade Estadual de Ponta Grossa | Ponta Grossa | Paraná | 84030-900 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2013 | |
| Reset | May 31, 2013 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2013 | May 31, 2013 |
| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014073 | Tooth Bleaching |
| D006861 | Hydrogen Peroxide |
| ID | Term |
|---|---|
| D004955 | Esthetics, Dental |
| D003813 | Dentistry |
| D010545 | Peroxides |
| D010087 | Oxides |
| D000838 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |