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The efficacy and safety of a whitening mouthrinse: randomized controlled clinical trial

Grant number: 18/23892-8
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): December 01, 2019
Effective date (End): October 31, 2022
Field of knowledge:Health Sciences - Dentistry - Dental Clinics
Principal researcher:Alessandra Buhler Borges
Grantee:Mariane Cintra Mailart
Home Institution: Instituto de Ciência e Tecnologia (ICT). Universidade Estadual Paulista (UNESP). Campus de São José dos Campos. São José dos Campos , SP, Brazil
Associated scholarship(s):20/13036-7 - Influence of hydrogen and carbamide peroxide-based bleaching agents on remineralization of white spots lesions, BE.EP.DR


Several techniques and products for tooth bleaching are available, among them, the over-thecounter products have become popular. However, evidence based on in vivo studies about tooth color change and adverse effects for the continuous use is not well established in literature. Thus, the aim of this randomized clinical trial is to evaluate the efficacy and safety of 2.5% hydrogen peroxide-based whitening mouthrinses and patients' satisfaction with whitening outcomes. Forty-five volunteers will be recruited and allocated in three treatment groups: LWE (Listerine Whitening Extreme-2.5% Hydrogen peroxide); OPF (Opalescence PF-10% Carbamide peroxide-positive control) and PL (Placebo mouthrinse-negative control). Bleaching treatment will be performed 1x/day for 14 days during 2h for OPF, and 2x/day for 90 days for LWE and PL. Tooth color will be evaluated subjectively with Vitapan Classical and Vita Bleachedguide 3D-MASTER scales, and objectively with spectrophotometer, adopting CIE L*a*b* parameters. Tooth sensitivity will be evaluated with numerical scale associated to visualanalogue scale, and gingival condition with Löe index. The potential of enamel demineralization will be measured with enamel microbiopsies; enamel superficial morphology with scanning electron microscopy; and volunteers' satisfaction will be investigated with questionnaires. The analysis will be performed in different times of treatment. Data will be submitted to appropriate statistical analysis, according to normality test, and significance level of 5% will be adopted. (AU)

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