Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
ID06583720

Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis - Controlled Randomized Clinical Trial

Led by University of Nove de Julho · Updated on 2025-03-30

92

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of halitosis showing sulfhydride (SH2) 65 112 ppb in gas chromatography.
  • Age between 18 and 60 years.
Not Eligible

You will not qualify if you...

  • Individuals with dentofacial anomalies such as cleft lip, cleft palate, and nasopalatine.
  • Undergoing orthodontic and/or orthopedic treatment.
  • Undergoing oncological treatment.
  • Having systemic alterations including gastrointestinal, renal, or hepatic conditions.
  • Receiving antibiotic treatment within 1 month before the study.
  • Pregnant women.

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

Nove de Julho University

São Paulo, São Paulo, Brazil, 01525-000

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Research Team

S

Sandra K Bussadori

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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Published Research Related To This Trial

Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial.

Amanda Rafaelly Honório Mandetta, Juliana Maria Altavista Sagretti Gallo, Caroline Diniz Pagani Vieira Ribeiro...

https://pubmed.ncbi.nlm.nih.gov/40280606