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

NCT06583720 | Recruiting Phase 1

• 1 other identifier: HaliFAPESP
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis

Outcome Measures

Primary Outcomes (1)

• Changes in Halimetry Levels

  The collection of oral air will follow the manufacturer\'s instructions (Oral ChromaTM Manual Instruction), where the participant will be instructed to rinse with cysteine (10 mM) for 1 minute, then keep their mouth closed for another minute. A syringe from the same manufacturer, suitable for collecting oral air, will be placed in the patient\'s mouth. For 1 minute, the patient will remain with their mouth closed, breathing through their nose, without touching the syringe with their tongue. The plunger will be pulled out, we will empty the air from the syringe into the patient\'s mouth again and pull the plunger again to fill the syringe with the breath sample. We will clean the tip of the syringe with gauze to remove moisture from the saliva, place the gas injection needle on the syringe, and adjust the plunger to 0.5 ml. The collected gases are injected into the inlet port of the device with a single movement.

  Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.

Secondary Outcomes (2)

• Changes in Microbiological Analysis

  Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.

• Changes in Microbiome Analysis

  Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.

Study Arms (4)

Control group

EXPERIMENTAL

Participants in this group will perform brushing, dental floss and tongue scraper.

Procedure: Oral hygiene at home

aPDT group

EXPERIMENTAL

Participants in this group will receive brushing, dental floss, tongue scraper and aPDT with blue LED and annatto.

Procedure: Oral hygiene at home; Procedure: aPDT

aPDT and Probiotics group

EXPERIMENTAL

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®).

Procedure: Oral hygiene at home; Procedure: aPDT; Dietary Supplement: Probiotics

Probiotics group

EXPERIMENTAL

Participants in this group will receive brushing, dental floss, lingual scraper and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).

Procedure: Oral hygiene at home; Dietary Supplement: Probiotics

Interventions

Oral hygiene at home PROCEDURE

Participant will be taught on how to correctly brush their teeth, use dental floss and scrape their tongues at home.

Control group; Probiotics group; aPDT and Probiotics group; aPDT group

aPDT PROCEDURE

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; aPDT group

Probiotics DIETARY_SUPPLEMENT

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; aPDT and Probiotics group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 01525-000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 40280606 DERIVED

MeSH Terms

Conditions

Halitosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Sandra K Bussadori

CONTACT

+55 11 2633-9000; pesquisa@uninove.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 4, 2024
• Study Start: November 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)