Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

January 20, 2021

Primary Completion Date

June 30, 2021

Study Completion Date

November 30, 2021

Conditions
Halitosis
Interventions
OTHER

Teeth brushing and flossing

All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.

OTHER

Tongue scraping

Tongue scraping will be performed by the same operator on all participants. Posterior-anterior movements will be performed with the scraper over the tongue dorsum, followed by cleaning the scraper with a gauze. This procedure will be performed ten times in each patient, in order to standardize the mechanical removal of the tongue coating.

RADIATION

Antimicrobial Photodynamic Therapy (aPDT)

One session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. The excess will be removed with a sucker in order to keep the surface wet with the PS itself, without using water. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.

BIOLOGICAL

Probiotics

Pharmacy-manipulated capsules containing strains of Lactobacillus salivarius WB21 (6.7 x 108 CFU) and xylitol (280mg) will be used. Forty-two capsules will be delivered for each patient, who should take 1 capsule 3 times a day after meals for 14 days.

Trial Locations (1)

01525-000

Universidade Nove de Julho, São Paulo

All Listed Sponsors
lead

University of Nove de Julho

OTHER

NCT03996044 - Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction | Biotech Hunter | Biotech Hunter