Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
NCT06583720

Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis

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

92

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Halitosis is a term that defines any odor or bad smell coming from the oral cavity, which can have a local or systemic origin. This project aims to verify if there is a difference in the effectiveness of treatment with antimicrobial photodynamic therapy (aPDT) with LED associated with treatment using probiotics in reducing halitosis. 92 participants, aged 18 to 60 years, diagnosed with halitosis, presenting sulfhydride (SH2) ≥ 112 ppb in gas chromatography will be selected. Participants will be randomly divided into 4 groups (n=23), which will receive different treatments: Group 1 (control): brushing, dental floss and tongue scraper; Group 2: brushing, dental floss, tongue scraper and aPDT with blue LED and annatto; Group 3: brushing, dental flossing, tongue scraper and aPDT with blue LED, annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®); Group 4: brushing, dental flossing, tongue scraper and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®). The results of the halimetry will be compared before, immediately after the treatments, thirty days after and sixty days after. The microbiological analysis will be performed by counting the colony forming unit of viable bacteria in the tongue coating at these same times. The microbiome analysis will be performed before, thirty days after and sixty days after the treatments after DNA extraction. All groups will be treated with oral hygiene instructions with a toothbrush, toothpaste and dental floss as well as receiving material for this practice. The normality of the data will be measured by the Shapiro-Wilk test, and in the case of normality the Analysis of Variance (ANOVA) test will be applied, and in the case of non-parametric data, the Kruskal-Wallis test will be used. The Wilcoxon test will be used to analyze the results of each treatment in the two study periods.

CONDITIONS

Official 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) 63 112 ppb in gas chromatography.
Not Eligible

You will not qualify if you...

  • Individuals with dentofacial anomalies such as cleft lip, cleft palate, or nasopalatine
  • Currently undergoing orthodontic or orthopedic treatment
  • Undergoing oncological treatment
  • Having systemic alterations affecting gastrointestinal, renal, or hepatic systems
  • Receiving antibiotic treatment within 1 month before the study
  • Pregnant women

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nove de Julho University

São Paulo, São Paulo, Brazil, 01525-000

Actively Recruiting

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Research Team

S

Sandra K Bussadori

CONTACT

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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