Evaluation of Halitosis After Treatment With Photodynamic Therapy
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      Halitosis is the term used to define an unpleasant odor emanating from the mouth. Some lung
      diseases, such as bronchiectasis, are among the extra-oral causes of this condition. However,
      no studies have evaluated the reasons and treatment of halitosis in the population of adults
      with bronchiectasis. Methods and analysis: A randomized, controlled trial is proposed.
      Halitosis will be evaluated based on the measurement of volatile sulfur compounds (VSC) using
      gas chromatography. The participants (n=40) with halitosis and bronchiectasis will be
      randomized into two groups: G1-treatment with photodynamic therapy (n = 20) or G2-cleaning of
      the tongue with a tongue scraper (n = 20). After the treatments, a second evaluation will be
      performed, along with a microbiological analysis (qPCR) for the identification of the
      bacteria P. gingivalis and T. denticola. If the halitosis persists, the participants will
      receive periodontal treatment. The evaluation of halitosis and the microbiological analysis
      will be repeated. If the halitosis is solved, the participants will return after three months
      for an additional evaluation. This protocol will determine the effectiveness of phototherapy
      regarding the reduction of halitosis in healthy older adults and those with bronchiectasis.
    

Detailed description: 
      A single-center, randomized, controlled, single-blind clinical trial was designed in
      accordance with the criteria recommended for interventional trials in the SPIRIT Statement.
      The project for the proposed study received approval from the Human Research Ethics Committee
      o fNove de Julho University(certificate number: 1057901).

      Selection of individuals - characterization of sample - Two groups will be composed of adults
      in treatment at the dental clinic of Nove de Julho University. After verbal and written
      explanations of the study, those who agree to participate will sign a statement of informed
      consent approved by the Human Research Ethics Committee of Nove de Julho University. The
      study will be conducted in compliance with the precepts stipulated in the Declaration of
      Helsinki (revised in Fortaleza, Brazil, 2013).
    

Intervention name(s): pdt experimental group; tongue scraper group
Intervention type(s): Device; Other
Intervention description(s): G1-40 patients Photodynamic therapy with methylene blue as photosensitizer
device irradiation with low intensity laser (wave length = 660 nm) 9J (Jaules) per point(6 points) and radiant 90 seconds PS will be applied in sufficient quantity to cover the middle third and back of the tongue and wait for 5 minutes.six points with the distances of 1 cm between them will be irradiated.; Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum. in order to promote the mechanical removal of tongue coating
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: bio-equivalence study enrollment: 80
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bronchiectasis:; photodynamic therapy; periodontal disease; randomized controlled clinical study