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Treatment of Halitosis With Photodynamic Therapy in Older Patients

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photodynamic therapy
Treatment with tongue scraper
Periodontal treatment
hygiene procedures for the mucosa and dentures
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis focused on measuring Halitosis, photodynamic therapy, bronchiectasis

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 60 years or older
  • Halitosis positive: ≥ 112 ppbin the gas chromatography test
  • Patients with or without a diagnosis of bronchiectasis
  • Patients 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
  • Patients with a diagnosis of cystic fibrosis (which, although is a lung disease, has a genetic etiology)
  • Patients with hypersensitivity to the photosensitizing agent used in PDT

Sites / Locations

  • University of Nove de Julho (UNINOVE)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

G1 dentate healthy older

G2 healthy older/dentures

G3 dentate older bronchiectasis

G4 older bronchiectasis /dentures

Arm Description

Treatment with Photodynamic therapy (n = 20). The dentate participants will received periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Treatment with Photodynamic therapy (n = 20). The participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Treatment with tongue scraper (n = 20). The dentate participants with bronchiectasis will received periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Treatment with tongue scraper (n = 20). The participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before these steps

Outcomes

Primary Outcome Measures

Halimetry (gas chromatography test)
The portable Oral ChromaTM will be used for the assessment of halitosis. A syringe will be placed in the patient's mouth with the plunger completely inserted and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air. This procedure will be repeated. The gas injection needle will be placed on the syringe and the plunger will be adjusted to 0.5 ml. This air will be injected into the input of the device in a single motion. This procedure will be done before and immediately after treatment.

Secondary Outcome Measures

Microbiological evaluation of tongue coating
for the identification of the bacteria P. gingivalis and T. denticola.

Full Information

First Posted
July 8, 2018
Last Updated
June 27, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03591484
Brief Title
Treatment of Halitosis With Photodynamic Therapy in Older Patients
Official Title
Treatment of Halitosis With Photodynamic Therapy in Older Patients: Protocol for a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
Halitosis, photodynamic therapy, bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1 dentate healthy older
Arm Type
Experimental
Arm Description
Treatment with Photodynamic therapy (n = 20). The dentate participants will received periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated before these steps
Arm Title
G2 healthy older/dentures
Arm Type
Experimental
Arm Description
Treatment with Photodynamic therapy (n = 20). The participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before these steps
Arm Title
G3 dentate older bronchiectasis
Arm Type
Active Comparator
Arm Description
Treatment with tongue scraper (n = 20). The dentate participants with bronchiectasis will received periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated before these steps
Arm Title
G4 older bronchiectasis /dentures
Arm Type
Active Comparator
Arm Description
Treatment with tongue scraper (n = 20). The participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before these steps
Intervention Type
Radiation
Intervention Name(s)
Photodynamic therapy
Intervention Description
Treatment with Photodynamic therapy. The evaluation of halitosis and the microbiological analysis will be repeated before this step
Intervention Type
Device
Intervention Name(s)
Treatment with tongue scraper
Intervention Description
Treatment with tongue scraper. The evaluation of halitosis and the microbiological analysis will be repeated before this step
Intervention Type
Procedure
Intervention Name(s)
Periodontal treatment
Intervention Description
Periodontal treatment will be performed with curettes and ultrassom. The evaluation of halitosis and the microbiological analysis will be repeated before this step
Intervention Type
Procedure
Intervention Name(s)
hygiene procedures for the mucosa and dentures
Intervention Description
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
Primary Outcome Measure Information:
Title
Halimetry (gas chromatography test)
Description
The portable Oral ChromaTM will be used for the assessment of halitosis. A syringe will be placed in the patient's mouth with the plunger completely inserted and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air. This procedure will be repeated. The gas injection needle will be placed on the syringe and the plunger will be adjusted to 0.5 ml. This air will be injected into the input of the device in a single motion. This procedure will be done before and immediately after treatment.
Time Frame
study completion an average of 1 year
Secondary Outcome Measure Information:
Title
Microbiological evaluation of tongue coating
Description
for the identification of the bacteria P. gingivalis and T. denticola.
Time Frame
study completion an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 60 years or older Halitosis positive: ≥ 112 ppbin the gas chromatography test Patients with or without a diagnosis of bronchiectasis Patients 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 Patients with a diagnosis of cystic fibrosis (which, although is a lung disease, has a genetic etiology) Patients with hypersensitivity to the photosensitizing agent used in PDT
Facility Information:
Facility Name
University of Nove de Julho (UNINOVE)
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

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Treatment of Halitosis With Photodynamic Therapy in Older Patients

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