Efficacy of Laser Application in Dental Bleaching

Study Overview
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Brief Summary
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Objective: To establish the efficacy of laser application with chemical treatment in dental bleaching compared to chemical treatment alone. Methods: The investigators conducted a randomized controlled trial (RCT), single blind (evaluator), in 24 patients randomized to laser and chemical intervention (12) or chemical intervention aloe (12). The commercial products used were Whiteness Hp 35% Hydrogen Peroxide and the LASER of DCM Equipments. The trial outcome measures were obtained using the Vita EasyShade Spectrophotometer and the International CIELCh system. To stablish differences before vs. after treatments and between groups, the T test and chi2 tests were applied.

Detailed Description
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New technologies continue to be launched in the field of dental esthetics, especially for whitening, and many products advertise their efficacy. One new approach is the use of LASER technology which has been purported to be the most powerful font light for bleaching Diverse studies by different designs find different efficacies for LASER whitening Randomized clinical trials (RCT) are needed for the most rigorous confirmation of efficacy. RCT are able to control for characteristics that can cause bias, including factors related to dental care such as diet and cleaning behavior after the bleaching procedure. The investigators therefore conducted an RCT to make a side by side comparison of a LASER whitening technique with chemical bleaching versus chemical bleaching without LASER. Intervention: After the patient was informed and sign the consent; a dental prophylaxis was done. Three days later the bleaching procedure started following the same protocol regarding to the time and product used (35% Hydrogen Peroxide Whitening HP, 40 minutes divided in two phases of 20 minutes each one) from premolar to premolar in superior and inferior teeth. The difference was that one of the intervention groups used the Laser for ten minutes (starting at the minute 5) and the other did not.. The Laser used was the Whitening Lase II (DCM EQUIPMENTS). The measure of the color was done to the superior canines by just one evaluator in three stages: before bleaching (baseline), 15 minutes after bleaching, and three days after. It was done with the Vita Easyshade Spectrophotometer. The dental sensitivity also was asked at the three time points; however, as an exclusion criterion the level had to be 0 to be entered into the study. All the patients received verbal and written instructions about eating and cleaning behavior. Cleaning materials for the three days after procedure were given. As the clinical endpoint, the difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. A verbal numeric scale was used to determine the dental sensitivity with values from 0 to 3. The evaluator used the water and air from the dental chair syringe. The patient reports 0 for no sensitivity; 1 for slight sensitivity, 2 for moderate sensitivity, and 3 for severe sensitivity.

Official Title
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Efficacy of Laser Application in Dental Bleaching: A Randomized Clinical Trial

Conditions
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Tooth Discoloration

Intervention / Treatment
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* Device: Laser Application for Dental Bleaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who wanted to bleach or whiten their teeth. Exclusion Criteria: Patients who have a color less than A2 according to the Vita Scale Patients with dental sensitivity caries or restorations periodontal disease dental abfraction or attrition pregnant women, smokers patients with orthodontics nauseous reflects patients who did not wish to sign the consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Interventional Model Description: The investigators conducted a Randomized controlled trial (RCT) to study the effect of LASER in dental bleaching in 24 patients in Paraguay in 2015.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Application<br>35% Hydrogen Peroxide (Whitening HP, FGM SC Brazil) 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes Laser Application and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. Experimental | Device: Laser Application for Dental Bleaching<br>* The Laser used was the Whitening Lase II (DCM EQUIPMENTS).<br>|
| No Intervention: No Laser Application<br>35% Hydrogen Peroxide (Whitening HP FGM SC Brazil), 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes waiting and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. No Laser Application No Intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Color Stage 1(Before Intervention) | The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H. | through study completion, an average of 3 days | 
| Dental Color Stage 2 (30 minutes after dental bleaching) | The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H. | through study completion, an average of 3 days | 
| Dental Color Stage 3 (3 days after dental bleaching) | The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H. | through study completion, an average of 3 days | 
| Change in Color (Stage 3 - Stage 1) | The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention. | through study completion, an average of 3 days | 
| Change in Color (Stage 2 - Stage 1) | The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention. | through study completion, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate Dental Sensitivity | The dental sensitivity was asked 15 minutes after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less sensitivity is going to be better. | through study completion, an average of 3 days | 
| Mediate Dental Sensitivity | The dental sensitivity was asked 3 days after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less Sensitivity is going to be better. | through study completion, an average of 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleaching, Laser, CIELCH