Clinical Effectiveness of In-office Bleaching Activated With a LED/Laser Device
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tooth Discoloration |
Procedure: in-office bleaching with/without light |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Color Change and Sensitivity Level for In-office Bleaching With and Without a LED/Laser Device |
- Change in color [ Time Frame: at the 2-week recall ] [ Designated as safety issue: No ]
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.
- Prevalence and intensity of tooth sensitivity [ Time Frame: 24-hours after the bleaching ] [ Designated as safety issue: Yes ]The visual analog scale will be used for patients to record their tooth sensitivity in a 0 to 10 scale.
| Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
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| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Brazil | |
| School of Dentistry - Universidade Estadual de Ponta Grossa | |
| Ponta Grossa, Paraná, Brazil, 84030-900 | |
| Principal Investigator: | Alessandra Reis, DDS, MS | Universidade Estadual de Ponta Grossa |
More Information
No publications provided
| Responsible Party: | Alessandra Reis, PhD, Universidade Estadual de Ponta Grossa |
| ClinicalTrials.gov Identifier: | NCT01231243 History of Changes |
| Other Study ID Numbers: | ARAL001 |
| Study First Received: | October 28, 2010 |
| Last Updated: | December 5, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Universidade Estadual de Ponta Grossa:
|
tooth bleaching, bleaching agent, hydrogen peroxide |
Additional relevant MeSH terms:
|
Tooth Discoloration Tooth Diseases Stomatognathic Diseases Hydrogen Peroxide |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013