Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2018-12-05

Brief Summary

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Halitosis, also known as bad breath, is a term used to define an unpleasant and foul odor that emanates from the mouth and may have local or systemic origin. This project aims to observe the presence of halitosis and to verify if the treatment with antimicrobial photodynamic therapy (aPDT) is effective against it. The investigators will select 45 students or UNINOVE employees, from 18 to 25 years old, with a diagnosis of halitosis, presenting sulfite (SH2) ≥ 112 ppb on gas chromatography. Patients will be randomly divided into 3 groups of 15, which will receive different treatments: Group 1: treatment with tongue scraper; Group 2: aPDT applied in the back region and middle third of the tongue; Group 3: combined treatment of tongue scraper and aPDT. For the aPDT we will use urucum manipulated in the 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, associated with a LED (Valo Cordless Ultradent®). 6 points will be irradiated on the back of the tongue with a distance of 1 cm between the points, 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. The results of the halimetry will be compared before and immediately after the treatment, besides the microbiological analysis of the tongue coating, before and after the treatment. The normality of the data will be measured using the Shapiro-Wilk test, and in the case of normality the Variance Analysis (ANOVA) test will be applied, and in the case of non-parametric data, the Kruskal-Wallis test will be used. To analyze the results of each treatment in both periods of the study, the Wilcoxon test will be used.

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Detailed Description

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Conditions

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Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tongue scraper group (Group 1)

Fifteen patients will be included in this group. Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual 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.

Group Type EXPERIMENTAL

Tongue Scraping

Intervention Type OTHER

Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual 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.

aPDT group (Group 2)

Fifteen patients will be included in this group. 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.

Group Type EXPERIMENTAL

aPDT

Intervention Type RADIATION

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.

Tongue scraper and aPDT (Group 3)

Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual 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. After, 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. 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.

Group Type EXPERIMENTAL

Tongue scraper and aPDT

Intervention Type RADIATION

Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual 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. After, 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. 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.

Interventions

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Tongue Scraping

Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual 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.

Intervention Type OTHER

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.

Intervention Type RADIATION

Tongue scraper and aPDT

Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual 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. After, 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. 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.

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes