HalitosisHalitosisNCT03996915
Evaluation of Halitosis After Treatment With Photodynamic Therapy Associated With Periodontal Treatment
A study testing Pdt Photodynamic Therapy and tongue scrapper in people with Halitosis, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- Pdt Photodynamic Therapy and tongue scrapper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 1 Dec 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders
- with at least 10 teeth
- Periodontal screening and recording (PSR) 0, 1 or 2
- without any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
- positive halitosis (SH2 level higher than 112 ppb).
Who cannot join
- smokers
- ex-smokers for less than 5 years
- patients with hypersensitivity to the photosensitizer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Halitosis in Adult Patients After Treatment With Photodynamic Therapy Associated With Periodontal Treatment: Protocol for a Randomized, Controlled Single Blinded Trial With 3-month Follow up
The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy or G2-cleaning of the tongue with a tongue scraper . Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola
Read the detailed description
Halitosis is an unpleasant odor that emanating from the mouth. A recent metanalysis shows worldwide trend towards a rise in halitosis prevalence. Studies show halitosis returns in a week after treatment with photodynamic therapy (PDT). Probably, bacteria residing in the periodontal sulcus could recolonize the dorsum of the tongue. To date, there are no study in adult population that associate halitosis and periodontal treatment with follow-up evaluation. The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants (n=40) with halitosis 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). Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola. The evaluation of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and three months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile (OHIP-14) Comparisons will be made with ANOVA test, with the level of significance of 5 %. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults.
- Conditions
- Halitosis
- Being tested
- Pdt Photodynamic Therapy, tongue scrapper
- Keywords
- photodynamic therapy, periodontal disease, randomized controlled clinical study
- Medical subject headings
- Halitosis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pdt Photodynamic TherapyDevice
device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) 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 scrapperOther
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
| Study group | Role | What they receive |
|---|---|---|
| experimental PDT group | Experimental | G1-20 patients Photodynamic therapy with methylene blue as photosensitizer device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) per point (6 points) and radiant 90 seconds. Photosensitiser (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. Receives: Device: Pdt Photodynamic Therapy |
| control tongue scrapper group | Active comparator | G2-20 patients 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 Receives: Other: tongue scrapper |
What is being measured
The primary outcome is the main question the study is designed to answer.
halitosis measurement (gas chromatography test)
The portable Oral Chroma will be used for the assessment of halitosis. Oral air collection will follow the manufactured guide lines (Oral Chroma Manual Instruction). 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, immediately after PDT or scraper and after periodontal treatment.
Measured: through study completion on average of one year
Secondary outcomes (1)
microbiological analysis
collecting biofilm sample from the region of the lingual dorsum with swab and identification of the bacteria P. gingivalis and T. denticola. Sample will be transferred to sterile tubes with ethylenediaminetetraacetic acid (tris-EDTA). The analysis will be performed by PCR (polymerase Chain reaction) real time
Measured: through study completion on average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jan 2019
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Bio-equivalence Study Enrollment:40
- Masking
- Single blind
- Who is masked
- Investigator
- 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
- Investigators
- Anna Carolina rt Horliana, phd, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996915
- Sponsor's protocol ID
- Halitosis healthy patients
- Acronym
- Halitosis
- Status last verified
- Dec 2019
- First submitted
- 22 Jun 2019
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Silva T, da Silva FC, Gomes AO, Viana AO, Goncalves MLL, Rodrigues MFSD, Horliana ACRT, da Silva DFT, Chavantes MC, Fragoso YD, Branco LP, Motta LJ, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Effect of photobiomodulation treatment in the sublingual, radial artery region, and along the spinal column in individuals with multiple sclerosis: Protocol for a randomized, controlled, double-blind, clinical trial. Medicine (Baltimore). 2018 May;97(19):e0627. doi: 10.1097/MD.0000000000010627.
PubMed 29742699Sobral APT, Godoy CLH, Fernandes KPS, Bussadori SK, Ferrari RAM, Horliana ACRT, Monken SF, Motta LJ. Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis. BMJ Open. 2018 May 5;8(5):e018326. doi: 10.1136/bmjopen-2017-018326.
PubMed 29730613da Cunha Moraes G, Vitoretti LB, de Brito AA, Alves CE, de Oliveira NCR, Dos Santos Dias A, Matos YST, Oliveira-Junior MC, Oliveira LVF, da Palma RK, Candeo LC, Lino-Dos-Santos-Franco A, Horliana ACRT, Gimenes Junior JA, Aimbire F, Vieira RP, Ligeiro-de-Oliveira AP. Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor. Oxid Med Cell Longev. 2018 Mar 4;2018:6798238. doi: 10.1155/2018/6798238. eCollection 2018.
PubMed 29686745Romero SDS, Schalch TO, do Vale KL, Ando ES, Mayer MPA, Feniar JPG, Fernandes KPS, Bussadori SK, Motta LJ, Negreiros RM, Tempestini Horliana ACR. Evaluation of halitosis in adult patients after treatment with photodynamic therapy associated with periodontal treatment: Protocol for a randomized, controlled, single-blinded trial with 3-month follow up. Medicine (Baltimore). 2019 Sep;98(39):e16976. doi: 10.1097/MD.0000000000016976.
PubMed 31574796
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
- Evaluation of Halitosis in Adult Patients After Treatment With Photodynamic Therapy Associated With Periodontal Treatment: Protocol for a Randomized, Controlled Single Blinded Trial With 3-month Follow up
- ClinicalTrials.gov ID
- NCT03996915
- Acronym / sponsor ID
- Halitosis / Halitosis healthy patients
- Conditions
- Halitosis
- Keywords
- photodynamic therapy, periodontal disease, randomized controlled clinical study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 25 Jun 2019 (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.
The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy or G2-cleaning of the tongue with a tongue scraper . Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola
Detailed description
Halitosis is an unpleasant odor that emanating from the mouth. A recent metanalysis shows worldwide trend towards a rise in halitosis prevalence. Studies show halitosis returns in a week after treatment with photodynamic therapy (PDT). Probably, bacteria residing in the periodontal sulcus could recolonize the dorsum of the tongue. To date, there are no study in adult population that associate halitosis and periodontal treatment with follow-up evaluation. The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants (n=40) with halitosis 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). Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola. The evaluation of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and three months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile (OHIP-14) Comparisons will be made with ANOVA test, with the level of significance of 5 %. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Bio-equivalence Study Enrollment:40
| Arm | Type | Receives |
|---|---|---|
| experimental PDT group | Experimental | Device: Pdt Photodynamic TherapyG1-20 patients Photodynamic therapy with methylene blue as photosensitizer device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) per point (6 points) and radiant 90 seconds. Photosensitiser (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. |
| control tongue scrapper group | Active comparator | Other: tongue scrapperG2-20 patients 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both genders
- with at least 10 teeth
- Periodontal screening and recording (PSR) 0, 1 or 2
- without any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
- positive halitosis (SH2 level higher than 112 ppb).
Key exclusion criteria (3 listed)
- smokers
- ex-smokers for less than 5 years
- patients with hypersensitivity to the photosensitizer.
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 |
|---|---|---|
| Pdt Photodynamic Therapydevice irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) 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. | Device | experimental PDT group |
| tongue scrapperTongue 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 | Other | control tongue scrapper group |
Primary outcome
halitosis measurement (gas chromatography test)
Time frame: through study completion on average of one year
The portable Oral Chroma will be used for the assessment of halitosis. Oral air collection will follow the manufactured guide lines (Oral Chroma Manual Instruction). 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, immediately after PDT or scraper and after periodontal treatment.
1 secondary outcome
microbiological analysis
Time frame: through study completion on average of one 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.
- Background: PubMed 29742699da Silva T, da Silva FC, Gomes AO, Viana AO, Goncalves MLL, Rodrigues MFSD, Horliana ACRT, da Silva DFT, Chavantes MC, Fragoso YD, Branco LP, Motta LJ, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Effect of photobiomodulation treatment in the sublingual, radial artery region, and along the spinal column in individuals with multiple sclerosis: Protocol for a randomized, controlled, double-blind, clinical trial. Medicine (Baltimore). 2018 May;97(19):e0627. doi: 10.1097/MD.0000000000010627.
- Background: PubMed 29730613Sobral APT, Godoy CLH, Fernandes KPS, Bussadori SK, Ferrari RAM, Horliana ACRT, Monken SF, Motta LJ. Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis. BMJ Open. 2018 May 5;8(5):e018326. doi: 10.1136/bmjopen-2017-018326.
- Background: PubMed 29686745da Cunha Moraes G, Vitoretti LB, de Brito AA, Alves CE, de Oliveira NCR, Dos Santos Dias A, Matos YST, Oliveira-Junior MC, Oliveira LVF, da Palma RK, Candeo LC, Lino-Dos-Santos-Franco A, Horliana ACRT, Gimenes Junior JA, Aimbire F, Vieira RP, Ligeiro-de-Oliveira AP. Low-Level Laser Therapy Reduces Lung Inflammation in an Experimental Model of Chronic Obstructive Pulmonary Disease Involving P2X7 Receptor. Oxid Med Cell Longev. 2018 Mar 4;2018:6798238. doi: 10.1155/2018/6798238. eCollection 2018.
- Derived from this study: PubMed 31574796Romero SDS, Schalch TO, do Vale KL, Ando ES, Mayer MPA, Feniar JPG, Fernandes KPS, Bussadori SK, Motta LJ, Negreiros RM, Tempestini Horliana ACR. Evaluation of halitosis in adult patients after treatment with photodynamic therapy associated with periodontal treatment: Protocol for a randomized, controlled, single-blinded trial with 3-month follow up. Medicine (Baltimore). 2019 Sep;98(39):e16976. doi: 10.1097/MD.0000000000016976.
- Individual participant dataSharing planned: No
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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.
Anna Carolina rt Horliana, phd principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pdt Photodynamic Therapy and tongue scrapper 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 5 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?
halitosis measurement (gas chromatography test) (time frame: through study completion on average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996915, which also lists 4 linked publications.
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.