Study Results
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Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-07-02
2020-07-02
Brief Summary
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Detailed Description
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This study was approved by the research ethics committee of School of Dentistry of University of Sao Paulo (Protocol# 1.981.756). The experimental design is in according to CONSORT. The present research will be a blind, parallel and randomized study with similar allocation between the treatment groups. It will be included 200 participants, selected among the patients of the Special Laboratory of lasers in dentistry (LELO-FOUSP). After being being informed of the objectives of the study the participants will be randomly divided into a treatment group (n = 25):
G1 - In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week).
G2 - In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week).
G3 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week).
G4 - In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week).
G5 - In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week).
G6 - In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week).
G7 - hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week).
G8 - Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).
The primary outcome of this study is the color alteration, which will be evaluated quantitatively by colorimetric (subjective) and spectrophotometric (objective) tests. Additionally, will be evaluated dental sensitivity during and after treatment (predetermined times), patient satisfaction regarding the treatment, and impact on patient quality of life (questionnaire OHIP-14).
The color measurement will be blind, in predetermined times (before the treatment, immediately after the treatment, 14 days after, 3 months after, 6 months after and 12 months after). It will be performed by two methods: subjectively, with a color scale; and objectively, with a clinical spectrophotometer.
The evaluation of dental sensitivity will be measured with a Visual analogue scale (VAS). It will be performed immediately after the treatment and 48 hours after the treatment.
The patient satisfaction regarding the treatment will be measured with a questionnaire for self-evaluation of the treatment, and will be applied 14 days after the end of treatment, 3 months after, 6 months after and 12 months after.
The evaluation of quality of life of the patients will be performed with the OHIP-14 questionnaire, which will be applied after the end of the treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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G1 - 35% Hydrogen peroxide bleaching
In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week);
35% Hydrogen peroxide bleaching
Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
G2 - 30% Carbamide peroxide bleaching
In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week);
30% Carbamide peroxide bleaching
Protocol: Application of 35% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
G3 - Violet LED bleaching 1
In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week);
Violet LED bleaching 1
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
G4 - Violet LED bleaching 2
In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week);
Violet LED bleaching 2
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 2 times a week.
G5 - Photochemical protocol 1
In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week);
Photochemical protocol 1
Protocol: Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
G6 - Photochemical protocol 2
In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week)
Photochemical protocol 2
Protocol: Application of 30% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
G7 - Hybrid technique 1
hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week)
Hybrid technique 1
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 35% Hydrogen peroxide to act concomitantly with the light.
G8 - Hybrid technique 2
Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week).
Hybrid technique 2
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 30% Carbamide peroxide to act concomitantly with the light.
Interventions
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35% Hydrogen peroxide bleaching
Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
30% Carbamide peroxide bleaching
Protocol: Application of 35% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
Violet LED bleaching 1
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Violet LED bleaching 2
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 2 times a week.
Photochemical protocol 1
Protocol: Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Photochemical protocol 2
Protocol: Application of 30% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
Hybrid technique 1
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 35% Hydrogen peroxide to act concomitantly with the light.
Hybrid technique 2
Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 30% Carbamide peroxide to act concomitantly with the light.
Eligibility Criteria
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Inclusion Criteria
* Patients presenting the canine tooth color A3 (according to Vita classical scale) or darker.
Exclusion Criteria
* Patients presenting periodontal diseases
* Smokers or patients with systematic use of alcohol
* Patients presenting teeth with color alterations by tetracycline, fluorosis, endodontic treatments.
* Patients with historic of self-referenced sensitivity
* Pregnant or Breastfeeding period patients
* Presence of restorations on anterior teeth
* Patients presenting bruxism or systematic use of analgesics or anti-inflammatory drugs
18 Years
30 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Patricia Moreira de Freitas
Associate Professor
Principal Investigators
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Patricia Freitas, PhD
Role: STUDY_CHAIR
Associate Professor
Locations
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School of Dentistry of USP
São Paulo, São Paulo, Brazil
Countries
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References
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Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
Boushell LW, Ritter AV, Garland GE, Tiwana KK, Smith LR, Broome A, Leonard RH. Nightguard vital bleaching: side effects and patient satisfaction 10 to 17 years post-treatment. J Esthet Restor Dent. 2012 Jun;24(3):211-9. doi: 10.1111/j.1708-8240.2011.00479.x. Epub 2011 Oct 11.
Other Identifiers
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010
Identifier Type: -
Identifier Source: org_study_id