Clinical trial NCT06583720: Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis
Official title: Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis - Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Halitosis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of halitosis showing sulfhydride (SH2) ≥ 112 ppb in gas chromatography.

Exclusion Criteria:

* Individuals with dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
* 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.

Primary outcomes:
measure: Changes in Halimetry Levels
timeFrame: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.
Secondary outcomes:
measure: Changes in Microbiological Analysis
timeFrame: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.
measure: Changes in Microbiome Analysis
timeFrame: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
state: SP
Study officials:
References: