Effect of Gel Renewal During In-office Dental Bleaching

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Gel Renewal During In-office Dental Bleaching Using Violet LED Light as Photo-accelerator. A Randomized Blind Clinical Trial

Conditions
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Tooth Bleaching

Intervention / Treatment
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* Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good oral hygiene conditions Good general health conditions and without systemic disease Presence of all teeth, without caries, periodontal disease, restorations, endodontic treatment, crowns Patients with dental color A3 or darker, according to the VITA * Classical Color Scale. Exclusion Criteria: Pregnant and lactating female patients Presence of caries, periodontal disease or any other infectious source in the oral cavity Systematic use of tobacco and alcoholic beverages Chronic use of corticosteroids, as well as who makes use of analgesics or anti-inflammatories before or during 48 hours after dental bleaching Patients with dentin hypersensitivity Patients with tooth color alteration by tetracycline, fluorosis, endodontic treatment. Volunteers who use removable prostheses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Split-mouth model design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G1 - Permanence of the Whitening Gel<br>Permanence of the Whitening Gel (Biological Product: 35% Hydrogen Peroxide) on the tooth enamel during the 15 minutes of dental-bleaching | Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation<br>* After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED<br>|
| Experimental: G2 - Renewal of the Whitening Gel<br>3 Whitening Gel (Biological Product: 35% Hydrogen Peroxide) renewal every 5 minutes during the 15 minutes of dental-bleaching | Other: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation<br>* After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |