HalitosisPhase 1/2NCT05590897
Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children
A Phase 1/2 study testing Teeth Brushing, Dental Flossing and Tongue Scraping in people with Halitosis, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Objective: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Halitosis
- What is being tested?
- Teeth Brushing, Dental Flossing and Tongue Scraping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2023to 20 Dec 2023
- Phase
- Phase 1/2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of mouth breathing (performed using the calibrated Glatzel mirror test, water retention test and a questionnaire);
- Halitosis presenting a score equal or greater than 2, in the Breath Alert analysis.
Who cannot join
- Nasal breathers;
- Dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
- Undergoing orthodontic and/or orthopedic treatment;
- Undergoing cancer treatment;
- Systemic alterations (gastrointestinal, renal, hepatic);
- Under antibiotic treatment for up to 1 month before the research;
- Fissured or grooved tongue.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Metropolitana de Santos - UNIMES
Santos, São Paulo, 11045-002
About this study
Official title: Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children: Randomized Controlled Clinical Trial
Objective: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. Methods: Fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on Breath Alert® portable breath meter) were randomly allocated to two groups (n = 26). Group 1: brushing, dental floss and aPDT applied to middle third of the dorsum of the tongue. Group 2: brushing, dental floss and tongue scraper. Breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. The normality of the data will be determined using the Shapiro-Wilk test. Parametric data will be submitted to analysis of variance and nonparametric data will be compared using the Kruskal-Wallis test. The results of each treatment in the different periods of the study will be compared using the Wilcoxon test.
- Conditions
- Halitosis
- Being tested
- Teeth Brushing, Dental Flossing, Tongue Scraping, Antimicrobial Photodynamic Therapy (aPDT)
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teeth BrushingProcedure or surgery
All 52 participants were instructed through a lecture on how to perform toothbrushing with a fluoridated toothpaste (Colgate T®) and dental flossing three times per day after meals for 30 days. The Bass technique was taught, by which the bristles should be positioned at an approximate angle of 45º to the gingival pocket on both the free and proximal faces, with the performance of short, slightly circular vibrating movements.
Dental FlossingProcedure or surgery
All 52 participants were instructed to floss, 3 times a day after meals for 30 days.
Tongue ScrapingProcedure or surgery
Tongue scraping was performed by the same operator for all participants. Posteroanterior movements were performed with the scraper on the dorsum of the tongue, followed by the cleaning of the scraper with gauze. The procedure was performed ten times on each participant to standardize mechanical removal.
Antimicrobial Photodynamic Therapy (aPDT)Radiation
One session of aPDT was performed. The annatto photosensitizer was mixed at a concentration of 20% (Fórmula e Ação®, Brazil) in spray form, applied with a sufficient quantity to coat the middle third of the dorsum of the tongue (five sprays) and left for two minutes for incubation. The excess was removed with an aspirator. |The surface of the tongue remained moist with the photosensitizer itself without the use of water. Six points were irradiated with a distance of 1 cm between points, considering the spread of the light and effectiveness of aPDT. The device was previously calibrated at a wavelength of 395-480 nm. Light was irradiated to ensure a beam area of 2 cm in diameter per point. Energy was 9.6 J and exposure time was 20 seconds per point.
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial Photodynamic Therapy Group | Experimental | Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue. Receives: Procedure: Teeth Brushing; Procedure: Dental Flossing; Radiation: Antimicrobial Photodynamic Therapy (aPDT) |
| Tongue Scraping Group | Experimental | Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping. Receives: Procedure: Teeth Brushing; Procedure: Dental Flossing; Procedure: Tongue Scraping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Halimetry Results
The Breath Alert® device was used following the manufacturer's instructions and disinfected after each use. The device was shaken four or five times prior to each use to eliminate any residual odors. A "beep" was emitted upon opening the upper compartment of the device and a second "beep" was emitted when the participant blew into the frontal air input (air flow passage). After a third "beep", breath odor was measured and scored on a scale of 0 to 8 points. If the letter ''C'' appeared, indicating an error, the procedure was repeated. A score ≥ 2 points was considered indicative of halitosis.
Measured: Baseline, immediately after treatment, after 7 days and after 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Feb 2023
- Primary completion1 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590897
- Sponsor's protocol ID
- MouthBreathing
- Status last verified
- Mar 2024
- First submitted
- 19 Oct 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bruno LH, Sobral APT, Goncalves MLL, Fossati AL, Santos EM, Gallo JMAS, Ferri EP, Motta PB, Prates RA, Deana AM, Horliana ACRT, Motta LJ, Bussadori SK. Comparative study between photodynamic therapy and the use of probiotics in the reduction of halitosis in mouth breathing children: Study protocol for a randomized controlled clinical trial. Medicine (Baltimore). 2023 Apr 14;102(15):e33512. doi: 10.1097/MD.0000000000033512.
PubMed 37058047
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05590897
- Acronym / sponsor ID
- MouthBreathing
- Conditions
- Halitosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 21 Oct 2022 (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.
Objective: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. Methods: Fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on Breath Alert® portable breath meter) were randomly allocated to two groups (n = 26). Group 1: brushing, dental floss and aPDT applied to middle third of the dorsum of the tongue. Group 2: brushing, dental floss and tongue scraper. Breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. The normality of the data will be determined using the Shapiro-Wilk test. Parametric data will be submitted to analysis of variance and nonparametric data will be compared using the Kruskal-Wallis test. The results of each treatment in the different periods of the study will be compared using the Wilcoxon test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Photodynamic Therapy Group | Experimental | Procedure: Teeth Brushing, Procedure: Dental Flossing, Radiation: Antimicrobial Photodynamic Therapy (aPDT)Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue. |
| Tongue Scraping Group | Experimental | Procedure: Teeth Brushing, Procedure: Dental Flossing, Procedure: Tongue ScrapingParticipants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of mouth breathing (performed using the calibrated Glatzel mirror test, water retention test and a questionnaire);
- Halitosis presenting a score equal or greater than 2, in the Breath Alert analysis.
Key exclusion criteria (7 listed)
- Nasal breathers;
- Dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
- Undergoing orthodontic and/or orthopedic treatment;
- Undergoing cancer treatment;
- Systemic alterations (gastrointestinal, renal, hepatic);
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 |
|---|---|---|
| Teeth BrushingAll 52 participants were instructed through a lecture on how to perform toothbrushing with a fluoridated toothpaste (Colgate T®) and dental flossing three times per day after meals for 30 days. The Bass technique was taught, by which the bristles should be positioned at an approximate angle of 45º to the gingival pocket on both the free and proximal faces, with the performance of short, slightly circular vibrating movements. | Procedure or surgery | Antimicrobial Photodynamic Therapy Group, Tongue Scraping Group |
| Dental FlossingAll 52 participants were instructed to floss, 3 times a day after meals for 30 days. | Procedure or surgery | Antimicrobial Photodynamic Therapy Group, Tongue Scraping Group |
| Tongue ScrapingTongue scraping was performed by the same operator for all participants. Posteroanterior movements were performed with the scraper on the dorsum of the tongue, followed by the cleaning of the scraper with gauze. The procedure was performed ten times on each participant to standardize mechanical removal. | Procedure or surgery | Tongue Scraping Group |
| Antimicrobial Photodynamic Therapy (aPDT)One session of aPDT was performed. The annatto photosensitizer was mixed at a concentration of 20% (Fórmula e Ação®, Brazil) in spray form, applied with a sufficient quantity to coat the middle third of the dorsum of the tongue (five sprays) and left for two minutes for incubation. The excess was removed with an aspirator. |The surface of the tongue remained moist with the photosensitizer itself without the use of water. Six points were irradiated with a distance of 1 cm between points, considering the spread of the light and effectiveness of aPDT. The device was previously calibrated at a wavelength of 395-480 nm. Light was irradiated to ensure a beam area of 2 cm in diameter per point. Energy was 9.6 J and exposure time was 20 seconds per point. | Radiation | Antimicrobial Photodynamic Therapy Group |
Primary outcome
Changes in Halimetry Results
Time frame: Baseline, immediately after treatment, after 7 days and after 30 days.
The Breath Alert® device was used following the manufacturer's instructions and disinfected after each use. The device was shaken four or five times prior to each use to eliminate any residual odors. A "beep" was emitted upon opening the upper compartment of the device and a second "beep" was emitted when the participant blew into the frontal air input (air flow passage). After a third "beep", breath odor was measured and scored on a scale of 0 to 8 points. If the letter ''C'' appeared, indicating an error, the procedure was repeated. A score ≥ 2 points was considered indicative of halitosis.
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 1 Apr 2024.
- Derived from this study: PubMed 37058047Bruno LH, Sobral APT, Goncalves MLL, Fossati AL, Santos EM, Gallo JMAS, Ferri EP, Motta PB, Prates RA, Deana AM, Horliana ACRT, Motta LJ, Bussadori SK. Comparative study between photodynamic therapy and the use of probiotics in the reduction of halitosis in mouth breathing children: Study protocol for a randomized controlled clinical trial. Medicine (Baltimore). 2023 Apr 14;102(15):e33512. doi: 10.1097/MD.0000000000033512.
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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 Phase 1/2 study testing Teeth Brushing, Dental Flossing and Tongue Scraping 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 2 inclusion and 7 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 1 Apr 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in Halimetry Results (time frame: Baseline, immediately after treatment, after 7 days and after 30 days.). 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 NCT05590897, which also lists 1 linked publication.
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 1 Apr 2024.