Clinical evaluation of in-office tooth whitening with violet LED (405 nm): A double-blind randomized controlled clinical trial.

BACKGROUND: Although there is little evidence showing the effectiveness of violet LED on in-office tooth whitening, there are some studies which have reported satisfactory results. This double-blind randomized controlled clinical trial aimed to evaluate the effect of a violet light emission diode (LED) (405 nm) system, used in-office, on tooth whitening, sensitivity, use of medication after whitening and quality of life. METHODS: Eight patients were randomized into 4 groups (n = 20): G1 - violet LED, G2 - 35% carbamide peroxide (CP) and violet LED, G3 only CP 35% and G4 35% hydrogen peroxide (HP). The color was measured using a spectrophotometer at the following times: baseline, 15 and 180days. The colorimetric changes were analyzed using measurements from the CieLab System ΔE (ΔL, Δa and Δb) and the WID (Whiteness Index for Dentistry) for the 4 groups. Tooth sensitivity was recorded via a visual analog scale (VAS). Additionally, the Psychosocial Impact of Dental. Aesthetics Questionnaire (PIDAQ) was used to evaluate quality of life. RESULTS: For the analysis of ΔL, G4 and G2 presented more brightness than G1 and G3 (p<0.05), implying that G2 is at least as good as G4 (p>0.05). For measure of Δa, G4 presented better results, standing out from the other groups. (p<0.05). For Δb, both G4 and G2 showed a greater tendency for blue color than groups G1 and G3 (p <0.05). When analyzing ∆E at the 180-day follow up, G4 produced the highest ∆E, while G3 showed the lowest ∆E. The other 2 whitening groups produced intermediate ∆E values. For ∆W, G1 and G3 significantly differed from G2 and G3. When analyzing the 180-day follow up, G2 produced the highest ∆W, while G3 showed the lowest ∆W. The other two whitening treatments produced intermediate ∆W values. As for sensitivity, only G4 patients showed dental sensitivity within 24 h of the bleaching, with pain ceasing after 48 h. For G4, 33% of the patients needed to take analgesics within the first 24 h after the first 3 whitening sessions. For PIDAQ, there was no overall decrease in score over time for any of the groups and there was no difference between them (p>0.05). CONCLUSION: Our results showed that violet LED was not able to whiten teeth at the same intensity, when used alone, as it was when associated with 35% CP, contrary to our initial hypothesis. However, given that pain was not consistently reported in G2, one could suggest that treatment with LED + 35% CP is quite similar to that of 35% HP when used for tooth whitening, but with better pain outcomes. All treatments suggested an improvement in quality of life.Clinical Trial Registry: This trial is registered at ClinicalTrials.gov; the registration number is NCT03192852 https://clinicaltrials.gov/ct2/show/NCT03192852.

Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial.

INTRODUCTION: In-office tooth whitening treatment using violet light emited diode (LED) (405 nm) is a novel bleaching method that causes less sensitivity while offering the same effectiveness as the gold standard (35% hydrogen peroxide, H2O2). This study describes a protocol for the first randomised controlled clinical trial to compare the effects of the two methods. METHODS AND ANALYSIS: Eighty patients will be divided into four groups: G1 violet LED; G2 violet LED +35% carbamide peroxide; G3 35% H2O2 and G4 violet LED +gingivoplasty. Colour will be measured at baseline, immediately after the first session and at the 15 and 180 days follow-up using the Vita Classical and the digital Easyshade V spectrophotometer (Vita, Zahnfabrik, Germany). Sensitivity after whitening will be measured using the Visual Analogue Scale at baseline and at each session in all groups and in all follow-ups. The tissue removed during gingivoplasty (G4) will be submitted to immunohistochemical analysis for the determination of inflammatory changes caused by violet LED. The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) will be evaluated before, as well as at established time point controls. The results will be expressed as mean and SD values. After determining the normality of the data, a one-way repeated-measures analysis of variance will be used for the comparison of data with normal distribution and the Kruskal-Wallis test will be used for data with non-normal distribution. A p<0.05 will be considered indicative of statistical significance. After determining the normality of the data, the Kruskal-Wallis test will be used for non-parametric data. Multivariate analysis of variance (MANOVA) and the Wilcoxon test will be used for comparing data from the PIDAQ. ETHICS AND DISSEMINATION: This protocol has been approved by the Human Research Ethics Committee of UniversidadeNove de Julho (certificate: 2.034.518). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03192852; Pre-results.