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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and postoperative sensitivity in a randomized, blinded, split-mouth study. Thirty-three volunteers will be selected to participate in the study (n = 33), and the study groups will be: G1 (Permanence of the Whitening Gel on the tooth enamel for 15 minutes) and G2 (3 Whitening Gel renewal every 5 minutes - Total of 15 minutes). In both G1 and G2, teeth will be illuminated with the Violet LED (405-410nm). In the same patient the two treatments (G1 and G2) will be performed, with a split-mouth protocol. The primary outcome will be immediate and mediated color change, quantitatively assessed by colorimetric (color scale) and spectrophotometry tests. Dental sensitivity will also be evaluated during and after tooth whitening using the VAS pain scale. There will be 3 whitening sessions with a 7-day interval between them. The alteration of color and presence of sensitivity will also be evaluated at the times of 14 days and 2 months after the whitening ends. A gel containing 35% hydrogen peroxide will be used. The final color evaluator and responsible for interviewing the patient about the sensitivity will be blind as to which treatment was applied on each side of the patient's arcade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G1 - Permanence of the Whitening Gel | Experimental | Permanence of the Whitening Gel (Biological Product: 35% Hydrogen Peroxide) on the tooth enamel during the 15 minutes of dental-bleaching |
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| G2 - Renewal of the Whitening Gel | Experimental | 3 Whitening Gel (Biological Product: 35% Hydrogen Peroxide) renewal every 5 minutes during the 15 minutes of dental-bleaching |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation | Other | After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED |
| Measure | Description | Time Frame |
|---|---|---|
| Teeth Color 1 | assessed quantitatively by colorimetric color scale | Immediately after treatment |
| Teeth Color 2 | assessed quantitatively by spectrophotometry | Immediately after treatment |
| Teeth Color 1 | assessed quantitatively by colorimetric color scale | 14 days after treatment |
| Teeth Color 2 | assessed quantitatively by spectrophotometry | 14 days after treatment |
| Teeth Color 1 | assessed quantitatively by colorimetric color scale | 2 months after treatment |
| Teeth Color 2 | assessed quantitatively by spectrophotometry | 2 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dental sensitivity | Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain) | Immediately after treatment |
| Dental sensitivity | Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen M Ramalho, PhD | Contact | 11989385397 | +5511 | karenramalho@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Ibirapuera | Recruiting | São Paulo | São Paulo | 04661-100 | Brazil |
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Split-mouth model design
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| 14 days after treatment |
| Dental sensitivity | Evaluated through a Visual Analogic Scale (0-10cm) from 0 (no pain) to 10 (maximum pain) | 2 months after treatment |