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Clinical Trial Summary

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.


Clinical Trial Description

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 (SpectroShadeâ„¢ 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03192852
Study type Interventional
Source University of Nove de Julho
Contact
Status Completed
Phase N/A
Start date July 1, 2018
Completion date December 20, 2019

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