Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Introduction: Halitosis is a term that defines any foul odor emanating from the oral cavity.
      The origin may be local or systemic. The aim of the proposed project is to determine whether
      treatment with antimicrobial photodynamic therapy (aPDT) and treatment with probiotics are
      effective at eliminating halitosis. Methods and analysis: Fifty-two patients from 18 to 25
      years old with a diagnosis of halitosis (H2S≥112 ppb determined by gas chromatography) will
      be randomly allocated to four groups (n=13) who will receive different treatments: Group 1 -
      treatment with teeth brushing, dental floss and tongue scraper; Group 2 - brushing, dental
      floss and aPDT; Group 3 - brushing, dental floss and probiotics; Group 4 - brushing,
      flossing, aPDT and probiotics. The results of the halimeter testing will be compared before,
      immediately after, seven days and thirty days after treatment. The microbiological analysis
      of the coated tongue will be performed at these same times. The quantitative analysis will be
      conducted using real-time PCRq. The normality of the data will be determined using the
      Shapiro-Wilk test. Data with normal distribution will be analyzed using analysis of variance
      (ANOVA). Non-parametric data will be analyzed using the Kruskal-Wallis test. The Wilcoxon
      test will be used to analyze the results of each treatment at the different evaluation
      periods. Ethics and dissemination: This study has been approved by the Ethics Committee of
      UNINOVE under process number 3.669.442. Results will be published in peer-reviewed journals
      and will be presented at national and international conferences.
    


Intervention name(s): Teeth brushing and flossing; Tongue scraping; Antimicrobial Photodynamic Therapy (aPDT); Probiotics
Intervention type(s): Other; Other; Radiation; Biological
Intervention description(s): All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.; Tongue scraping will be performed by the same operator on all participants. Posterior-anterior movements will be performed with the scraper over the tongue dorsum, followed by cleaning the scraper with a gauze. This procedure will be performed ten times in each patient, in order to standardize the mechanical removal of the tongue coating.; One session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. The excess will be removed with a sucker in order to keep the surface wet with the PS itself, without using water. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.; Pharmacy-manipulated capsules containing strains of Lactobacillus salivarius WB21 (6.7 x 108 CFU) and xylitol (280mg) will be used. Forty-two capsules will be delivered for each patient, who should take 1 capsule 3 times a day after meals for 14 days.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment