Evaluation of the use of photobiomodulation following the placement of elastomeric separators: Protocol for a randomized controlled clinical trial.

BACKGROUND: Pain stemming from the placement of elastomeric separators and the exchanging of wires and accessories is the greatest reason for abandoning orthodontic treatment. Indeed, discomfort related to treatment exerts a negative impact on quality of life due to the difficulty chewing and biting. This paper proposes a study to evaluate the analgesic effects of photomiobodulation (PBM) on individuals undergoing orthodontic treatment. METHODS: The sample will be composed of 72 individuals who receiving elastomeric separators on the mesial and distal faces of the maxillary first molars. The patients will be randomly allocated to 2 groups: an experimental group irradiated with low-level laser and a sham group submitted to simulated laser irradiation. Upon the placement of the separators, the experimental group will receive a single application of PBM on the mesial and distal cervical portion and apical third of the molars. Perceived pain will be analyzed after one hour using the visual analog scale in both groups. Samples will be taken of the gingival crevice with absorbent paper for 30 seconds for the analysis of cytokines using ELISA and the results of the 2 groups will be compared. The patients will sign a statement of informed consent. Statistical analysis will be performed with the Student's t test and analysis of variance (ANOVA). DISCUSSION: The expectation is that the patients in the irradiated group will have a lower perception of pain and lower quantity of cytokines compared to those in the sham group. The purpose of the study is to establish an effective method for PBM with the use of low-level infrared laser (Ga-Al-As with a wavelength of 808 nm and output power of 100 mW) for reductions in pain and inflammatory cytokines related to orthodontic treatment. TRIAL REGISTRATION: This protocol was registered in ClinicalTrial.gov, under number NCT03939988. It was first posted and last updated in May 6, 2019.

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.