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We aim to evaluate colorimetric changes after supervised whitening treatment, using Violet LED light associated or not with carbamide peroxide 35% gel. 80 will be divided into: Group 1 - Violet LED light, Group 2 Violet LED light + carbamide peroxide 35% gel, Group 3 -hydrogen peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for aesthetic desire, after whitening treatment with Violet LED light without gel. The colorimetric changes will be measured before, right after each whitening session in the end of the period of 3 months, through the Vitapan Classical (Vita) color scale, and by digital spectrophotometer. The sensibility degree will be measured by the Visual Analogue Scale (VAS) . The gum tissues Group 4, will be analyzed by histomorphometrically. Quality of life will be evaluated.
This randomized, blind controlled trial has the objective of evaluate colorimetric changes after supervised whitening treatment, in-office, using Violet LED light of 405 nm associated or not to the use of carbamide peroxide 35% gel. Eighty patients, of which 20 with aesthetics desires to be submitted to gingivoplasty surgery, will be divided into four groups. Group 1 will receive whitening only with Violet LED light (405 nm). Group 2 will receive a whitening treatment combination of Violet LED light with carbamide peroxide 35% gel. Patients of Group 3 will receive a whitening treatment with hydrogen peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for aesthetic desire, after whitening treatment with Violet LED light (405 nm) without gel. The colorimetric changes will be measured before, right after each whitening session in the end of the period of 3 months, through the Vitapan Classical (Vita) color scale, and by digital spectrophotometer (SpectroShade™ Micro MHT Optic Research). The sensibility degree will be measured by the Visual Analogue Scale (VAS) in each session and in all groups. The gum tissues removed during the gingivoplasty in Group 4, will be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation. The degree of satisfaction of the patient and the life quality after aesthetic result achieved will be evaluated. The results will be presented by means and standard deviation. After checking the normality of the data, a one-way ANOVA will be performed. In case the data do not follow a normal distribution, it will be utilized the Kruskal-Wallis test and a value of p <0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Violet LED (405 nm)+ gel placebo | Experimental | 20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier + gel placebo |
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| Violet LED + CP 35% | Active Comparator | 20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with carbamide peroxide 35% ( Whiteform - Fórmula & Ação, São Paulo, Brazil) actived with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier |
|
| HP 35% | Active Comparator | 20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with hydrogen peroxide 35% (Whiteness HP, FGM, Joinvile, SC, Brasil) and gingival barrier |
|
| HP 35% + Violet LED + Gingivoplasty | Experimental | 20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier split-mouth at first session. After 48 hours will be do Gingivoplasty. |
|
| CP 35% |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental bleaching | Other | dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel |
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| Measure | Description | Time Frame |
|---|---|---|
| Color Evaluation | Color evaluation will be done before and after each bleaching session through the Vita Classical scale (VITA Zanhnfabrik, BadSӓckingrn, Germany) and SpectroShade ™ Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups | baseline |
| Color Evaluation | Color evaluation will be done 3 months after bleaching through the Vita Classical scale (VITA Zanhnfabrik, BadSӓckingrn, Germany) and SpectroShade ™ Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain measured with Visual Analogue Scale (VAS) | The pain will be evaluated through the Visual Analogue Scale (VAS) at each session before and after bleaching in the 4 groups. | baseline |
| Pain measured with Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana EC Santos, MS | University of Nove de Julho | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nove de Julho (UNINOVE) | São Paulo | 01504-001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34116249 | Derived | Santos AECG, Bussadori SK, Pinto MM, Brugnera AJ, Zanin FAA, Silva T, Martinbianco ALC, Pantano Junior DA, Rodrigues MFSD, Artese HPC, Deana AM, Motta LJ, Horliana ACRT. Clinical evaluation of in-office tooth whitening with violet LED (405 nm): A double-blind randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102385. doi: 10.1016/j.pdpdt.2021.102385. Epub 2021 Jun 9. | |
| 30181185 |
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After completing the data search, it is published in indexed journals with high impact factor
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| ID | Term |
|---|---|
| C093177 | tooth-bleaching agent, Opalescence |
| D005893 | Gingivoplasty |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D010517 | Periodontics |
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We will use a gel with no effect only in the fourth session of group 3 to match the number of sessions in relation to the other groups
20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with carbamide peroxide 35% ( Whiteform - Fórmula & Ação, São Paulo, Brazil) |
|
| Gingivoplasty | Procedure | gengivoplasty will be realized to in illuminated tissue an no illuminated tissue to morphometrically evaluate the tissue |
|
The pain will be assessed through the Visual Analogue Scale (VAS) 3 months after the end of tooth whitening in the 4 groups.
| 3 months |
| Quality of life measured with Psychosocial Impact Questionnaire | Quality of life will be assessed through the Psychosocial Impact of Dental Aesthetics Questionnaire validated for Brazil at the Federal University of São Paulo (UNIFESP) | baseline |
| Quality of life measured with Psychosocial Impact Questionnaire | Quality of life will be evaluated through the Psychosocial Impact Questionnaire of the Dental Internship validated for Brazil at the Federal University of São Paulo (UNIFESP) 3 months after the end of the bleaching. | 3 months |
| Histomorphometric evaluation | will be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation. | baseline |
| Derived |
| Santos AECGD, Bussadori SK, Pinto MM, Pantano Junior DA, Brugnera A Jr, Zanin FAA, Rodrigues MFSD, Motta LJ, Horliana ACRT. Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial. BMJ Open. 2018 Sep 4;8(9):e021414. doi: 10.1136/bmjopen-2017-021414. |