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

NCT ID: NCT01231243

Last Updated: 2011-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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

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Tooth Discoloration

Keywords

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tooth bleaching, bleaching agent, hydrogen peroxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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35% hydrogen peroxide control

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

Group Type ACTIVE_COMPARATOR

in-office bleaching with/without light

Intervention Type 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.

20% hydrogen peroxide

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

Group Type ACTIVE_COMPARATOR

in-office bleaching with/without light

Intervention Type 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.

35% hydrogen peroxide + light

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

Group Type EXPERIMENTAL

in-office bleaching with/without light

Intervention Type 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.

20% hydrogen peroxide + light

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

Group Type EXPERIMENTAL

in-office bleaching with/without light

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Tooth bleaching Hydrogen peroxide In-office bleaching Light activation Hydrogen peroxide concentration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Estadual de Ponta Grossa

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Reis

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra Reis, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual de Ponta Grossa

Locations

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School of Dentistry - Universidade Estadual de Ponta Grossa

Ponta Grossa, Paraná, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ARAL001

Identifier Type: -

Identifier Source: org_study_id