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Completed

NCT Number: NCT01231243

Clinical Effectiveness of In-office Bleaching Activated With 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.

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Key information

Conditions

Tooth Discoloration Stomatognathic Diseases Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

School of Dentistry - Universidade Estadual de Ponta Grossa

Ponta Grossa, Paraná, 84030-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Tooth bleaching, Hydrogen peroxide, In-office bleaching, Light activation, Hydrogen peroxide concentration

Primary outcomes

  1. Change in color

    Time frame: at the 2-week recall

    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.

Secondary outcomes

  1. Prevalence and intensity of tooth sensitivity

    Time frame: 24-hours after the bleaching

    The visual analog scale will be used for patients to record their tooth sensitivity in a 0 to 10 scale.

Sponsors and collaborators

Lead sponsor

Universidade Estadual de Ponta Grossa

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 1, 2010
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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