It is known that the presence of orthodontic brackets predisposes for a change in both the quantity and quality of the biofilm, due to the challenge of brushing adequately. The sites are difficult to access with a toothbrush and periodontal curette, worsening inflammation. In addition, gingival hyperplasia is frequently associated with poor hygiene. The hypothesis to be tested in this study is whether photodynamic therapy (PDT) could favor the decontamination of these areas, as the photosensitizer and light are capable of reaching areas that these instruments have difficulty accessing. In other words, the objective of this study is to evaluate the impact of PDT as an adjuvant treatment to scaling, considering clinical immunoregulatory and microbiological parameters in patients with gingivitis with the predisposing factor of the use of a fixed orthodontic appliance. A randomized, controlled, double-blind clinical study will include 34 patients, both genders, having used the fixed appliance for more than 12 months, with gingivitis present. Patients will be divided into two groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and Experimental group (n = 17) - SRP + PDT. In G2 methylene blue 0.005%, λ = 660nm, 9J (joule) per inflamed site, irradiance = 3.5W / cm, radiant exposure = 318J / cm2 . In G1 the scaling will be performed with the aid of curettes and ultrasound. All participants will receive oral hygiene guidance (OHG) prior to SRP. The clinical periodontal data to be analyzed: plaque index (PI), gingival index (GI) and probing depth (PD) and clinical level of insertion (CLI) by means of a periodontal probe. Crevicular fluid (from 8 pre-determined sites) and non-stimulated saliva for analysis of the IL-6, IL-1β, IL-8, TNF-α and IL-10 cytokines will be collected using the ELISA method. In addition, the Universal bacteria count (16S rRNA gene) will also be performed by qPCR using the same secretions. All analysis will be realized using the baseline (T0), 7 (T1) and 21 (T2) days after treatment. Oral health-related quality of life (OHRQoL) will be assessed using the OHIP-14 questionnaire at times T0 and T2. If sample distribution is normal, the Student T-test will be used to compare the measurement of continuous and dependent variables. If it is not normal, the Mann-Whitney test will be used. The data will be presented in terms of ± PD and the value of p will be defined as 0.05.
The hypothesis to be tested in this study is whether photodynamic therapy (PDT) could favor the decontamination of these areas, as the photosensitizer and light are capable of reaching areas that these instruments have difficulty accessing. In other words, the objective of this study is to evaluate the impact of PDT as an adjuvant treatment to scaling, considering clinical immunoregulatory and microbiological parameters in patients with gingivitis with the predisposing factor of the use of a fixed orthodontic appliance. A randomized, controlled, double-blind clinical study will include 34 patients, Patients will be divided into two groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and Experimental group (n = 17) - SRP + PDT. In G2 methylene blue 0.005%, λ = 660nm, 9J (joule) per inflamed site, irradiance = 3.5W / cm (watts/centimeter), radiant exposure = 318J / cm2. In G1 the scaling will be performed with the aid of curettes and ultrasound. All participants will receive oral hygiene guidance (OHG) prior to SRP. The clinical periodontal data to be analyzed: plaque index (PI), gingival index (GI) and probing depth (PD) and clinical level of insertion (CLI) by means of a periodontal probe. Crevicular fluid (from 8 pre-determined sites) and non-stimulated saliva for analysis of the IL-6 (interleukin), IL-1β, IL-8, TNF-α (tumor necrosis factor) and IL-10 cytokines will be collected using the ELISA method. In addition, the Universal bacteria count (16S rRNA gene- ribonucleic acid) will also be performed by qPCR (polymerase chain reaction) using the same secretions. Oral health-related quality of life (OHRQoL) will be assessed using the OHIP-14 (oral health impact profile) questionnaire