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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alessandra Reis, Universidade Estadual de Ponta Grossa
ClinicalTrials.gov Identifier:
NCT01231243
First received: October 28, 2010
Last updated: December 5, 2011
Last verified: December 2011
History of Changes

October 28, 2010
December 5, 2011
January 2011
September 2011   (final data collection date for primary outcome measure)
Change in color [ Time Frame: at the 2-week recall ] [ Designated as safety issue: No ]

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.
Same as current
Complete list of historical versions of study NCT01231243 on ClinicalTrials.gov Archive Site
Prevalence and intensity of tooth sensitivity [ Time Frame: 24-hours after the bleaching ] [ Designated as safety issue: Yes ]
The visual analog scale will be used for patients to record their tooth sensitivity in a 0 to 10 scale.
Same as current
Not Provided
Not Provided
 
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

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Tooth Discoloration
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.
Other Names:
  • Tooth bleaching
  • Hydrogen peroxide
  • In-office bleaching
  • Light activation
  • Hydrogen peroxide concentration
  • Active Comparator: 35% hydrogen peroxide control
    The tooth bleaching will be performed using a high hydrogen peroxide concentration (35%) without light-activation with LED/light device
    Intervention: Procedure: in-office bleaching with/without light
  • Active Comparator: 20% hydrogen peroxide
    The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) without light activation with a LED/laser device
    Intervention: Procedure: in-office bleaching with/without light
  • Experimental: 35% hydrogen peroxide + light
    The tooth bleaching will be performed with a high hydrogen peroxide concentration (35%) associated with LED/laser light activation
    Intervention: Procedure: in-office bleaching with/without light
  • Experimental: 20% hydrogen peroxide + light
    The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) associated with LED/laser light activation
    Intervention: Procedure: in-office bleaching with/without light
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants should be at least 18 years old;
  • Participants should have good general and oral health
  • Participants should have six caries-free maxillary anterior teeth without restorations on the labial surfaces
  • Participants should be willing to sign a consent form
  • Participants should have central incisors darker than shade C2.

Exclusion Criteria:

  • Participants that had undergone tooth-whitening procedures
  • Participants that had labial anterior restorations, were pregnant or lactating.
  • Participants with severe internal tooth discoloration (such as tetracycline stains, fluorosis, pulpless teeth).
  • Participants with bruxism habits or any gross pathology in the mouth
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01231243
ARAL001
No
Alessandra Reis, Universidade Estadual de Ponta Grossa
Universidade Estadual de Ponta Grossa
Not Provided
Principal Investigator: Alessandra Reis, DDS, MS Universidade Estadual de Ponta Grossa
Universidade Estadual de Ponta Grossa
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP