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

Primary Purpose

Tooth Discoloration

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
in-office bleaching with/without light
Sponsored by
Universidade Estadual de Ponta Grossa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tooth Discoloration focused on measuring tooth bleaching, bleaching agent, hydrogen peroxide

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dentistry - Universidade Estadual de Ponta Grossa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

35% hydrogen peroxide control

20% hydrogen peroxide

35% hydrogen peroxide + light

20% hydrogen peroxide + light

Arm Description

The tooth bleaching will be performed using a high hydrogen peroxide concentration (35%) without light-activation with LED/light device

The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) without light activation with a LED/laser device

The tooth bleaching will be performed with a high hydrogen peroxide concentration (35%) associated with LED/laser light activation

The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) associated with LED/laser light activation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 28, 2010
Last Updated
December 5, 2011
Sponsor
Universidade Estadual de Ponta Grossa
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1. Study Identification

Unique Protocol Identification Number
NCT01231243
Brief Title
Clinical Effectiveness of In-office Bleaching Activated With a LED/Laser Device
Official Title
Color Change and Sensitivity Level for In-office Bleaching With and Without a LED/Laser Device
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Ponta Grossa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
Keywords
tooth bleaching, bleaching agent, hydrogen peroxide

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
35% hydrogen peroxide control
Arm Type
Active Comparator
Arm Description
The tooth bleaching will be performed using a high hydrogen peroxide concentration (35%) without light-activation with LED/light device
Arm Title
20% hydrogen peroxide
Arm Type
Active Comparator
Arm Description
The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) without light activation with a LED/laser device
Arm Title
35% hydrogen peroxide + light
Arm Type
Experimental
Arm Description
The tooth bleaching will be performed with a high hydrogen peroxide concentration (35%) associated with LED/laser light activation
Arm Title
20% hydrogen peroxide + light
Arm Type
Experimental
Arm Description
The tooth bleaching will be performed with a low hydrogen peroxide concentration (20%) associated with LED/laser light activation
Intervention Type
Procedure
Intervention Name(s)
in-office bleaching with/without light
Other Intervention Name(s)
Tooth bleaching, Hydrogen peroxide, In-office bleaching, Light activation, Hydrogen peroxide concentration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in color
Description
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
Secondary Outcome Measure Information:
Title
Prevalence and intensity of tooth sensitivity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Reis, DDS, MS
Organizational Affiliation
Universidade Estadual de Ponta Grossa
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry - Universidade Estadual de Ponta Grossa
City
Ponta Grossa
State/Province
Paraná
ZIP/Postal Code
84030-900
Country
Brazil

12. IPD Sharing Statement

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

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