NCT01231243

Clinical Effectiveness of In-office Bleaching Activated With a LED/Laser Device

Color Change and Sensitivity Level for In-office Bleaching With and Without a LED/Laser Device

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universidade Estadual de Ponta Grossa · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tooth Discoloration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-11-01
• Last updated: 2011-12-06

Locations

1 site across 1 country: Brazil