HalitosisNCT03591484
Treatment of Halitosis With Photodynamic Therapy in Older Patients
A study testing Photodynamic therapy, Treatment with tongue scraper and Periodontal treatment in people with Halitosis, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- Photodynamic therapy, Treatment with tongue scraper and Periodontal treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Halitosis With Photodynamic Therapy in Older Patients: Protocol for a Randomized, Controlled Trial
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.
Read the 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)
- Conditions
- Halitosis
- Being tested
- Photodynamic therapy, Treatment with tongue scraper, Periodontal treatment, hygiene procedures for the mucosa and dentures
- Keywords
- Halitosis, photodynamic therapy, bronchiectasis
- Medical subject headings
- Halitosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyRadiation
Treatment with Photodynamic therapy. The evaluation of halitosis and the microbiological analysis will be repeated before this step
Treatment with tongue scraperDevice
Treatment with tongue scraper. The evaluation of halitosis and the microbiological analysis will be repeated before this step
Periodontal treatmentProcedure or surgery
Periodontal treatment will be performed with curettes and ultrassom. The evaluation of halitosis and the microbiological analysis will be repeated before this step
hygiene procedures for the mucosa and denturesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| G1 dentate healthy older | Experimental | 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 Receives: Radiation: Photodynamic therapy; Procedure: Periodontal treatment |
| G2 healthy older/dentures | Experimental | 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 Receives: Radiation: Photodynamic therapy; Procedure: hygiene procedures for the mucosa and dentures |
| G3 dentate older bronchiectasis | Active comparator | 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 Receives: Device: Treatment with tongue scraper; Procedure: Periodontal treatment |
| G4 older bronchiectasis /dentures | Active comparator | 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 Receives: Device: Treatment with tongue scraper; Procedure: hygiene procedures for the mucosa and dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: study completion an average of 1 year
Secondary outcomes (1)
Microbiological evaluation of tongue coating
for the identification of the bacteria P. gingivalis and T. denticola.
Measured: study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jun 2019
- Primary completion1 Dec 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591484
- Sponsor's protocol ID
- Halidosos
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2018
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Halitosis With Photodynamic Therapy in Older Patients: Protocol for a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03591484
- Acronym / sponsor ID
- Halidosos
- Conditions
- Halitosis
- Keywords
- Halitosis, photodynamic therapy, bronchiectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| G1 dentate healthy older | Experimental | Radiation: Photodynamic therapy, Procedure: Periodontal treatmentTreatment 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 |
| G2 healthy older/dentures | Experimental | Radiation: Photodynamic therapy, Procedure: hygiene procedures for the mucosa and denturesTreatment 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 |
| G3 dentate older bronchiectasis | Active comparator | Device: Treatment with tongue scraper, Procedure: Periodontal treatmentTreatment 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 |
| G4 older bronchiectasis /dentures | Active comparator | Device: Treatment with tongue scraper, Procedure: hygiene procedures for the mucosa and denturesTreatment 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 |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapyTreatment with Photodynamic therapy. The evaluation of halitosis and the microbiological analysis will be repeated before this step | Radiation | G1 dentate healthy older, G2 healthy older/dentures |
| Treatment with tongue scraperTreatment with tongue scraper. The evaluation of halitosis and the microbiological analysis will be repeated before this step | Device | G3 dentate older bronchiectasis, G4 older bronchiectasis /dentures |
| Periodontal treatmentPeriodontal treatment will be performed with curettes and ultrassom. The evaluation of halitosis and the microbiological analysis will be repeated before this step | Procedure or surgery | G1 dentate healthy older, G3 dentate older bronchiectasis |
| hygiene procedures for the mucosa and denturesedentulous 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 | Procedure or surgery | G2 healthy older/dentures, G4 older bronchiectasis /dentures |
Primary outcome
Halimetry (gas chromatography test)
Time frame: study completion an average of 1 year
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.
1 secondary outcome
Microbiological evaluation of tongue coating
Time frame: study completion an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic therapy, Treatment with tongue scraper and Periodontal treatment in people with Halitosis, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Halimetry (gas chromatography test) (time frame: study completion an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.