Photodynamic Therapy in Patients With Gingivitis
Condition: Gingivitis; Orthodontic Appliance Complication; Photodynamic Therapy
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      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 in patients with gingivitis with the predisposing factor of the use
      of a fixed orthodontic appliance. A randomized, controlled, double-blind, split-mouth
      clinical study will include 17 patients. Patients will have their mouth divided into two
      groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and
      Experimental group (n = 17) - SRP + PDT. In G2 will be used methylene blue 0.005%, λ = 660nm,
      9J (joule) per inflamed site, irradiance = 3.5W / cm (watts/centimeter), radiant exposure =
      318J / cm2. In G1 and G2 the scaling will be performed with the aid of the ultrasound. All
      participants will receive oral hygiene guidance (OHG) after to the end of the study. 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 will be collected (from 8 pre-determined sites) for analysis of the IL-6 (interleukin),
      IL-1β, IL-8, TNF-α (tumor necrosis factor) and IL-10 cytokines, using the ELISA method.
    

Detailed description: 
      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 growth 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 and
      immunoregulatory parameters in patients with gingivitis with the predisposing factor of the
      use of a fixed orthodontic appliance. A randomized, controlled, double-blind, split-mouth
      clinical study will include 17 patients, both genders, having used the fixed appliance for
      more than 12 months, with gingivitis present. Patients will have their mouth 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 and G2 the
      scaling will be performed with the aid of the ultrasound. All participants will receive oral
      hygiene guidance (OHG) after to the end of the study. 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 will be collected (from 8
      pre-determined sites) for analysis of the IL-6, IL-1β, IL-8, TNF-α and IL-10 cyttokines,
      using the ELISA method. All analysis will be realized using the baseline (T0) and (T1) 30
      days after treatment. 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.
    

Intervention name(s): scaling and root planing (SRP) + PDT placebo; scaling and root planing (SRP) + PDT
Intervention type(s): Procedure; Procedure
Intervention description(s): Patientes will receive periodontal treatment (scaling and root planing - SRP) with the ultrasound. The SRP will be done in one session. The PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application.; patients will receive the same scaling and root planing treatment that placebo group.However the PDT will be done only on one side of mouth using methylene blue 0.005% .The red laser diode (λ = 660 nm) will be applied with an output power of 100mW . The laser head will be positioned in direct contact with the pseudo periodontal pockets.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will have their mouth divided into two groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and Experimental group (n = 17) - SRP + PDT.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment