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.

Study Overview

• Status: Completed
• Conditions: Tooth Discoloration
• Intervention / Treatment: Procedure: in-office bleaching with/without light

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Ponta Grossa, Paraná, Brazil, 84030-900
      • School of Dentistry - Universidade Estadual de Ponta Grossa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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: Hydrogen peroxide; Tooth bleaching; In-office bleaching; Light activation; Hydrogen peroxide concentration
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	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: Hydrogen peroxide; Tooth bleaching; In-office bleaching; Light activation; Hydrogen peroxide concentration
Experimental: 35% hydrogen peroxide + 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; 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: Hydrogen peroxide; Tooth bleaching; In-office bleaching; Light activation; Hydrogen peroxide concentration
Experimental: 20% hydrogen peroxide + 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.; Other Names: Hydrogen peroxide; Tooth bleaching; In-office bleaching; Light activation; Hydrogen peroxide concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universidade Estadual de Ponta Grossa
• Investigators: Principal Investigator: Alessandra Reis, DDS, MS, Universidade Estadual de Ponta Grossa

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: tooth bleaching, bleaching agent, hydrogen peroxide
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: ARAL001