Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis
NCT ID: NCT06583720
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
92 participants
INTERVENTIONAL
2024-11-01
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Participants in this group will perform brushing, dental floss and tongue scraper.
Oral hygiene at home
Participant will be taught on how to correctly brush their teeth, use dental floss and scrape their tongues at home.
aPDT group
Participants in this group will receive brushing, dental floss, tongue scraper and aPDT with blue LED and annatto.
Oral hygiene at home
Participant will be taught on how to correctly brush their teeth, use dental floss and scrape their tongues at home.
aPDT
A weekly aPDT session will be performed for a period of 30 days, with the photosensitizer (PS) annatto manipulated at a concentration of 20% (Fórmula e Ação®). 2 ml (quantity measured with a pipette) will be applied to the middle third and dorsum of the tongue for 2 minutes for incubation (pre-irradiation time). The excess will be removed with a suction device in order to keep the surface moist with the PS itself. Six points will be irradiated with a distance of 1 cm between them, considering the light scattering halo; the LED will be positioned at a distance from the tongue so as to form a 2 cm halo at each point. The device will be previously calibrated with a wavelength of 395-480 nm, for 20 seconds per point, energy of 9.6 J.
aPDT and Probiotics group
Participants in this group will receive brushing, dental floss, lingual scraper and aPDT with blue LED, annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).
Oral hygiene at home
Participant will be taught on how to correctly brush their teeth, use dental floss and scrape their tongues at home.
aPDT
A weekly aPDT session will be performed for a period of 30 days, with the photosensitizer (PS) annatto manipulated at a concentration of 20% (Fórmula e Ação®). 2 ml (quantity measured with a pipette) will be applied to the middle third and dorsum of the tongue for 2 minutes for incubation (pre-irradiation time). The excess will be removed with a suction device in order to keep the surface moist with the PS itself. Six points will be irradiated with a distance of 1 cm between them, considering the light scattering halo; the LED will be positioned at a distance from the tongue so as to form a 2 cm halo at each point. The device will be previously calibrated with a wavelength of 395-480 nm, for 20 seconds per point, energy of 9.6 J.
Probiotics
Probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®) (OralBiotic; Master Products, Fort Lauderdale, Florida, United States) will be used. Each patient will receive 60 lozenges, which should be allowed to dissolve slowly and completely in the mouth. Patients are instructed to use the lozenges twice a day for a period of 30 days.
Probiotics group
Participants in this group will receive brushing, dental floss, lingual scraper and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).
Oral hygiene at home
Participant will be taught on how to correctly brush their teeth, use dental floss and scrape their tongues at home.
Probiotics
Probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®) (OralBiotic; Master Products, Fort Lauderdale, Florida, United States) will be used. Each patient will receive 60 lozenges, which should be allowed to dissolve slowly and completely in the mouth. Patients are instructed to use the lozenges twice a day for a period of 30 days.
Interventions
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Oral hygiene at home
Participant will be taught on how to correctly brush their teeth, use dental floss and scrape their tongues at home.
aPDT
A weekly aPDT session will be performed for a period of 30 days, with the photosensitizer (PS) annatto manipulated at a concentration of 20% (Fórmula e Ação®). 2 ml (quantity measured with a pipette) will be applied to the middle third and dorsum of the tongue for 2 minutes for incubation (pre-irradiation time). The excess will be removed with a suction device in order to keep the surface moist with the PS itself. Six points will be irradiated with a distance of 1 cm between them, considering the light scattering halo; the LED will be positioned at a distance from the tongue so as to form a 2 cm halo at each point. The device will be previously calibrated with a wavelength of 395-480 nm, for 20 seconds per point, energy of 9.6 J.
Probiotics
Probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®) (OralBiotic; Master Products, Fort Lauderdale, Florida, United States) will be used. Each patient will receive 60 lozenges, which should be allowed to dissolve slowly and completely in the mouth. Patients are instructed to use the lozenges twice a day for a period of 30 days.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Undergoing orthodontic and/or orthopedic treatment;
* Undergoing oncological treatment;
* With systemic alterations (gastrointestinal, renal, hepatic)
* Undergoing antibiotic treatment up to 1 month before the research;
* Pregnant women.
18 Years
60 Years
ALL
No
Sponsors
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University of Nove de Julho
OTHER
Responsible Party
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Sandra Kalil Bussadori
Principal Investigator
Locations
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Nove de Julho University
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Mandetta ARH, Gallo JMAS, Ribeiro CDPV, Goncalves MLL, Sobral APT, Motta LJ, Horliana ACRT, Mesquita-Ferrari RA, Rodriguez VS, Prates RA, Duran CCG, Fernandes KPS, Bussadori SK. Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial. BMJ Open. 2025 Apr 25;15(4):e095544. doi: 10.1136/bmjopen-2024-095544.
Other Identifiers
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HaliFAPESP
Identifier Type: -
Identifier Source: org_study_id
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