Clinical trial NCT01231243: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Discoloration
Keywords: tooth bleaching, bleaching agent, hydrogen peroxide
Lead sponsor: Universidade Estadual de Ponta Grossa
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in color
timeFrame: at the 2-week recall
Secondary outcomes:
measure: Prevalence and intensity of tooth sensitivity
timeFrame: 24-hours after the bleaching
Other outcomes:
Locations:
city: Ponta Grossa
country: Brazil
facility: School of Dentistry - Universidade Estadual de Ponta Grossa
state: Paraná
Study officials:
affiliation: Universidade Estadual de Ponta Grossa
name: Alessandra Reis, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: