Clinical trial

Comparative Study Between Photodynamic Therapy Using Urucum + LED and Probiotics in Halitosis Reduction - Controlled Clinical Trial

Name

Pamella

Description

Introduction: Halitosis is a term that defines any foul odor emanating from the oral cavity. The origin may be local or systemic. The aim of the proposed project is to determine whether treatment with antimicrobial photodynamic therapy (aPDT) and treatment with probiotics are effective at eliminating halitosis. Methods and analysis: Fifty-two patients from 18 to 25 years old with a diagnosis of halitosis (H2S≥112 ppb determined by gas chromatography) will be randomly allocated to four groups (n=13) who will receive different treatments: Group 1 - treatment with teeth brushing, dental floss and tongue scraper; Group 2 - brushing, dental floss and aPDT; Group 3 - brushing, dental floss and probiotics; Group 4 - brushing, flossing, aPDT and probiotics. The results of the halimeter testing will be compared before, immediately after, seven days and thirty days after treatment. The microbiological analysis of the coated tongue will be performed at these same times. The quantitative analysis will be conducted using real-time PCRq. The normality of the data will be determined using the Shapiro-Wilk test. Data with normal distribution will be analyzed using analysis of variance (ANOVA). Non-parametric data will be analyzed using the Kruskal-Wallis test. The Wilcoxon test will be used to analyze the results of each treatment at the different evaluation periods. Ethics and dissemination: This study has been approved by the Ethics Committee of UNINOVE under process number 3.669.442. Results will be published in peer-reviewed journals and will be presented at national and international conferences.

Trial arms

Trial start

2021-01-20

Estimated PCD

2021-06-30

Trial end

2021-11-30

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Group 1, Group 2, Group 3, Group 4

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.

Arms:

Group 1

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.

Arms:

Group 2, Group 4

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.

Arms:

Group 3, Group 4

Size

Primary endpoint

Change in halimetry (gas chromatography)

Baseline, immediately after treatment, 7 days and 30 days after treatment.

Eligibility criteria

Inclusion Criteria: * Age between 18 and 25 years; * Sulphide (SH2) ≥ 112 ppb in the gas chromatography. Exclusion Criteria: * Dentofacial anomalies (such as cleft lip and cleft palate); * Undergoing orthodontic and/or orthopedic treatment; * Undergoing oncological treatment; * Systemic alterations (gastrointestinal, renal, hepatic); * Treatment with antibiotics up to 1 month before the survey; * Pregnant. * Individuals with fissured tongue

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}

Updated at

2023-08-18

1 organization

1 product

1 indication

Organization

University of Nove de Julho

Product

Probiotics

Indication

Bad breath