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

NCT01231243 | Completed Phase 4

• 1 other identifier: ARAL001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Discoloration

Keywords

tooth bleaching, bleaching agent, hydrogen peroxide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence and intensity of tooth sensitivity

  24-hours after the bleaching

Study Arms (4)

35% hydrogen peroxide control

ACTIVE COMPARATOR

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

20% hydrogen peroxide

ACTIVE COMPARATOR

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

35% hydrogen peroxide + light

EXPERIMENTAL

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

20% hydrogen peroxide + light

EXPERIMENTAL

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

Interventions

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.

Also known as: Tooth bleaching, Hydrogen peroxide, In-office bleaching, Light activation, Hydrogen peroxide concentration

20% hydrogen peroxide; 20% hydrogen peroxide + light; 35% hydrogen peroxide + light; 35% hydrogen peroxide control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Estadual de Ponta Grossa: lead

Study Sites (1)

School of Dentistry - Universidade Estadual de Ponta Grossa

Ponta Grossa, Paraná, 84030-900, Brazil

Location

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Tooth Bleaching; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Esthetics, Dental; Dentistry; Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals

Study Officials

• Alessandra Reis, DDS, MS

  Universidade Estadual de Ponta Grossa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

BR (1)