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

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• Halitosis 93

Halitosis

93 studies on the registry are indexed under Halitosis; 17 are open to participants now.

This study's planned enrollment of 92 is above the median of 45 across 79 interventional studies indexed under Halitosis.

Lead sponsor

University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Study arms

• Experimental
  Control group

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

  Procedure: Oral hygiene at home

• Experimental
  aPDT group

  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

• Experimental
  aPDT and Probiotics group

  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

• Experimental
  Probiotics group

  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

• ProcedureOral hygiene at home

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

• ProcedureaPDT

  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.

• Dietary supplementProbiotics

  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.

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.

   Time frame: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.

Secondary outcomes

1. Changes in Microbiological Analysis

   The samples will be collected with a swab on the back of the tongue, then placed in an eppendorf containing BHI (Brain Heart Infusion) serving as a transport medium, for later cultivation of these samples to be able to detect the total number of viable bacteria. Initially, the samples will be homogenized for 30 seconds in a Vortex apparatus, and then diluted in the order of 10-1 to 10-5 in a 96-well microtiter plate containing 180 microliters of PBS in each well. We take 20 microliters of each sample and follow the dilution sequence. After the dilution is performed, we will take 5 aliquots of 10 microliters of this suspension and they will be seeded in a petri dish with blood agar. The cultures will then be incubated for 72 hours at 37°C in an atmosphere of 85% nitrogen (N2), 10% carbon dioxide (CO2) and 5% hydrogen (H2), achieved through the use of an anaerobic generation system. This will provide visual access to the total number of viable bacteria in colony forming units (CFU).

   Time frame: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.

2. Changes in Microbiome Analysis

   Tongue coating samples will be collected from the posterior third of the tongue using a sterile swab and deposited in 1.5 mL centrifuge tubes containing Tris-EDTA buffer (10 mM Tris-HCL, 0.1 mM EDTA, pH 7.5) and stored at -80 °C. After thawing, the samples will be vortexed for one minute. DNA extraction will be performed using the Master Pure DNA Extraction Kit (Epicentre Technologies Corp., Chicago, IL, USA) according to the manufacturer\'s instructions. The purified DNA will be resuspended in TE buffer. The microbiome and variations between communities will be analyzed using pyrosequencing and 16S rRNA gene metagenomics methods.

   Time frame: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.

Individual participant data

Plan to share: Yes — Data will be added to OSF.

Data sharing details ↗ · osf.io