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The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life. After being informed of the objectives of the study, 200 participants will be selected and randomly divided into a treatment group (n = 25): G1 - 35% hydrogen peroxide (HP) (4 sessions, 1 session/week); G2 - 30% carbamide peroxide (CP) (4 sessions, 1 session/week); G3 - Violet LED (405-410 nm, 4 sessions, 1 session/week); G4 - Violet LED (405-410 nm, 4 sessions, 2 sessions/week); G5 - Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); G6 - 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 color evaluation will be performed at predetermined times (before and immediately after treatment, 14 days after completion of bleaching and 3, 6 and 12 months after completion of bleaching), and quantitatively evaluated by colorimetric tests (objective and subjective) and spectrophotometry. In addition, it will be evaluated the tooth sensitivity during and after (48 hours) tooth whitening (VAS Scale), satisfaction with the treatment and impact on quality of life (OHIP-14 questionnaire). The data, except for survey data of satisfaction (descriptive evaluation), will be subjected to statistical analysis to determine the homogeneity and normality of the sample and for comparison between treatment groups, considering a 5% significance level.
The objective of this clinical study is to evaluate the effect of the whitening treatment performed with the violet LED light (405-410 nm), with or without a bleaching gel, on the tooth color changes (immediate and long-term), tooth sensitivity, satisfaction of participants in relation to the technique and impact on their quality of life.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G1 - 35% Hydrogen peroxide bleaching | Active Comparator | In-office bleaching performed with 35% hydrogen peroxide (4 sessions, 1 session/week); |
|
| G2 - 30% Carbamide peroxide bleaching | Active Comparator | In-office bleaching performed with 30% carbamide peroxide (4 sessions, 1 session/week); |
|
| G3 - Violet LED bleaching 1 | Experimental | In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 1 session/week); |
|
| G4 - Violet LED bleaching 2 | Experimental | In-office bleaching performed with Violet LED (405-410 nm, 4 sessions, 2 sessions/week); |
|
| G5 - Photochemical protocol 1 | Experimental | In-office bleaching performed Violet LED associated to 35% hydrogen peroxide (4 sessions, 1 session / week); |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 35% Hydrogen peroxide bleaching | Procedure | Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions. |
| Measure | Description | Time Frame |
|---|---|---|
| Color alteration | The color measurement will be blind, in predetermined time (12 months after the treatment). It will be performed with a clinical spectrophotometer. | 12 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dental sensitivity | 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. | Immediately after the treatment and 48 hours after the treatment |
| Patient satisfaction regarding the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Freitas, PhD | Associate Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry of USP | São Paulo | São Paulo | 05508-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20166405 | Background | 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. | |
| 22691084 | Background | 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. |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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| G6 - Photochemical protocol 2 |
| Experimental |
In-office bleaching performed Violet LED associated to 30% carbamide peroxide (4 sessions, 1 session / week) |
|
| G7 - Hybrid technique 1 | Experimental | hybrid technique HP (Violet LED + application of 35% hydrogen peroxide + violet LED) (4 sessions, 1 session/week) |
|
| G8 - Hybrid technique 2 | Experimental | Hybrid technique CP HP (Violet LED + application of 30% carbamide peroxide + violet LED) (4 sessions, 1 session/week). |
|
| 30% Carbamide peroxide bleaching | Procedure | 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 | Procedure | 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 | Procedure | 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 | Procedure | 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 | Procedure | 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 | Procedure | 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 | Procedure | 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. |
|
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. |
| 14 days after the end of treatment, 3 months after, 6 months after and 12 months after |
| Quality of life of the patients | 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. | Immediately after the end of bleaching |
| Color change throughout 12 months with a visual color scale | The evaluation will be performed with a visual color scale | Before, immediately after, 14 days, 3 months, 6 months and 12 months after bleaching |
| Color change throughout 6 months with a clinical spectrophotometer | The evaluation will be performed with a clinical spectrophotometer | Before, immediately after, 14 days, 3 months and 6 months after bleaching |