A Phase 4 interventional study of in-office bleaching with/without light in Tooth Discoloration, sponsored by Universidade Estadual de Ponta Grossa. Completed at 1 site in Brazil. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-06.
Sponsored by Universidade Estadual de Ponta Grossa · Phase 4, Interventional, and Supportive care
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.
105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.
This study's enrollment of 60 is above the median of 48 across 97 interventional studies indexed under Tooth Discoloration.
Browse Tooth Discoloration studies →Universidade Estadual de Ponta Grossa is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The tooth bleaching will be performed using a high hydrogen peroxide concentration (35%) without light-activation with LED/light device
Procedure: in-office bleaching with/without light
The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) without light activation with a LED/laser device
Procedure: in-office bleaching with/without light
The tooth bleaching will be performed with a high hydrogen peroxide concentration (35%) associated with LED/laser light activation
Procedure: in-office bleaching with/without light
The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) associated with LED/laser light activation
Procedure: in-office bleaching with/without light
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.
Also known as: Tooth bleaching, Hydrogen peroxide, In-office bleaching, Light activation, Hydrogen peroxide concentration
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.
Time frame: at the 2-week recall
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.
Time frame: 24-hours after the bleaching
The record gives a start of Jan 2011, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Universidade Estadual de Ponta Grossa