Study Comparing Photodynamic Therapy with LED and Probiotics for Treating Halitosis in Adults Aged 18 to 60
Led by University of Nove de Julho · Updated on 2025-03-30
92
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Halitosis, or bad breath, is caused by odors from the mouth that may come from local or systemic sources. This research evaluates whether antimicrobial photodynamic therapy aPDT with LED light combined with probiotics is more effective in reducing halitosis compared to other treatments. The study is a randomized controlled clinical trial involving 92 adults aged 18 to 60 years diagnosed with halitosis and specific levels of sulfhydride gas.
Participants are randomly assigned to one of four groups a control group practicing brushing, flossing, and tongue scraping a group receiving those oral hygiene practices plus weekly aPDT with blue LED and annatto a group receiving aPDT combined with probiotic lozenges containing Streptococcus salivarius K12 and a group receiving oral hygiene plus the probiotic lozenges alone. The aPDT sessions are conducted weekly for 30 days, and probiotic lozenges are taken twice daily for the same period.
Throughout the study, halitosis levels are measured before treatment, immediately after, and at 30 and 60 days post-treatment using halimetry. Microbiological and microbiome analyses of tongue coating bacteria are performed at these same times. All participants receive oral hygiene instructions and materials. Data will be statistically analyzed to compare treatment effects. The overall study period extends until December 2025.
CONDITIONS
Brief Title
Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis
Research Team
S
Sandra K Bussadori
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Having systemic alterations including gastrointestinal, renal, or hepatic conditions.
Receiving antibiotic treatment within 1 month before the study.
Pregnant women.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 30 days
Participants receive oral hygiene instruction and may receive photodynamic therapy (aPDT) sessions and/or probiotic lozenges depending on their assigned group.
Weekly visits for aPDT sessions and daily probiotic use as instructed
Follow-up
Duration - 30 days
Participants are monitored for changes in halitosis and microbiological outcomes after treatment.
Visits immediately after treatment, 30 days after treatment, and 60 days after treatment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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