Treatment of Halitosis With Photodynamic Therapy in Older Patients
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 causes and treatment of halitosis in the population of older
      adults with bronchiectasis. Methods and analysis: A randomized, controlled trial is proposed.
      The patients will be divided into four groups: G1- healthy older adults with 10 teeth or more
      (n = 40); G2- healthy older adults who wear complete dentures (n = 40); G3- older adults with
      bronchiectasis and 10 teeth or more (n = 40); and G4- older adults with bronchiectasis who
      wear complete dentures (n = 40). Halitosis will be evaluated based on the measurement of
      volatile sulfur compounds using gas chromatography. The participants with halitosis will be
      randomized into two subgroups: treatment with photodynamic therapy (n = 20) or 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 dentate participants
      will received periodontal treatment and the edentulous participants will be submitted to
      hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the
      microbiological analysis will be repeated. If the halitosis is resolved, 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: 
      Methods:

      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
      of Universidade Nove de Julho (certificate number: 87160418.7.0000.5511).

      Selection of individuals - characterization of sample - One group will be composed of older
      adults (60 years or older) with a diagnosis of bronchiectasis in medical follow up at the
      Pulmonary Disease Clinic of the School of Medicine of the Universidade de São Paulo. 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 Universidade
      Nove de Julho. The group of healthy patients will be composed of patients in treatment at the
      dental clinic of Universidade Nove de Julho, who will receive clarifications regarding the
      study and will also sign a statement of informed consent. The study will be conducted in
      compliance with the precepts stipulated in the Declaration of Helsinki (revised in Fortaleza,
      Brazil, 2013).

      Calculation of sample size - To achieve an effect size of 0.40 among the four groups (PDT in
      healthy participants. PDT in patients with bronchiectasis, periodontal treatment or denture
      hygiene in healthy participants, periodontal treatment or denture hygiene in patients with
      bronchiectasis), assuming an alpha error of 0.05 and beta error of 0.80, the total sample
      will be 80 individuals (20 per group). The sample size calculation was performed using
      G*Power (version 3.1.9.2) (Faul, 2007).

      Inclusion criteria - Men and women aged 60 years or older, with or without a diagnosis of
      bronchiectasis, with more than 10 natural teeth or using complete upper and lower dentures.

      Exclusion criteria - smokers or ex-smokers having quit less than five years ago, a diagnosis
      of cystic fibrosis (which, although is a lung disease, has a genetic etiology) and
      hypersensitivity to the photosensitizing agent used in PDT.

      Training and calibration of examiner - An examiner (gold standard) will perform training and
      calibration exercises to maximize the reproducibility of the measurements. For such, 10
      individuals with halitosis will be evaluated using the Oral Chroma® device. These individuals
      will not participate in the main study. The intraclass correlation coefficient (ICC) will be
      calculated for the determination of intra-examiner agreement (≥ 0.90) with regard to the
      halitosis readings.

      Randomization - The 40 healthy dentate individuals will be randomized in two groups: Group A
      (20 individuals submitted to treatment with a tongue scraper) and Group B (20 individuals
      submitted to treatment with PDT). The 40 healthy edentulous individuals will be randomized in
      two groups: Group C (20 individuals submitted to treatment with a tongue scraper) and Group D
      (20 individuals submitted to treatment with PDT). Therefore, two independent randomizations
      will be performed for these distinct groups of individuals (dentate and edentulous). Opaque
      envelopes will be identified with sequential numbers (1 to 40) and will contain pieces of
      paper with the information of the corresponding experimental group (A or B and C or D). Block
      randomization will be performed in blocks of five patients (four blocks for both treatments;
      example of a block: AABAB). The envelopes will be sealed and kept in numerical order in a
      safe place until the time of the treatments. The randomization and preparation of the
      envelopes will be performed by a researcher who will not otherwise participate in the study.
      The same procedure will be performed for the patients with bronchiectasis. Randomization will
      be performed using Microsoft Excel, version 2013.

      Characterization of the study - The experimental design will consist of four groups: G1-
      healthy older adults with halitosis and 10 teeth or more (n = 40); G2- healthy older adults
      with halitosis who wear complete dentures (n = 40); G3- older adults with bronchiectasis who
      have halitosis and 10 teeth or more (n = 40); and G4- older adults with bronchiectasis who
      have halitosis and wear complete dentures (n = 40). The evaluation of halitosis and the
      microbiological analysis of the dorsum of the tongue will be performed at baseline (1st
      session), after treatment with PDT, periodontal treatment or denture hygiene (2nd session)
      and after three months (3rd session)
    

Intervention name(s): Photodynamic therapy; Treatment with tongue scraper; Periodontal treatment; hygiene procedures for the mucosa and dentures
Intervention type(s): Radiation; Device; Procedure; Procedure
Intervention description(s): Treatment with Photodynamic therapy. The evaluation of halitosis and the microbiological analysis will be repeated before this step; Treatment with tongue scraper. The evaluation of halitosis and the microbiological analysis will be repeated before this step; Periodontal treatment will be performed with curettes and ultrassom. The evaluation of halitosis and the microbiological analysis will be repeated before this step; edentulous participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before this step
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Halitosis; photodynamic therapy; bronchiectasis