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

Halitosis Clinical Trial

Official title:

Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis: a Clinical and Microbiological Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03346460
• Other study ID #: HALIURU
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2018
• Est. completion date: December 5, 2018

Study information

• Verified date: May 2018
• Source: University of Nove de Julho
• Contact: Marcela LL Gonçalves, MS
• Phone: +55113385-9010
• Email: marcelalleal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 5, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Halitosis

Intervention

Other:
• 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.

Radiation:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	UNINOVE	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Halimetry (gas chromatography)	Oral air collection will follow the manufacturer's guidelines (Oral ChromaTM Manual Instruction) where the participant will be instructed to rinse with cysteine (10 mM) for 1 minute, then remain with his/her mouth closed for 1 minute. A syringe from the same manufacturer for collection of mouth air will be introduced into the patient's mouth. During 1 minute the patient will remain closed mouth, breathing through the nose, without touching the syringe with the tongue. The plunger will be pulled out, we will re-empty the syringe air into the patient's mouth and again pull the plunger to fill the syringe with the breath sample. We will wipe the tip of the syringe with gauze to remove moisture from the saliva, place the gas injection needle in the syringe, and adjust the plunger to 0.5 ml. The gases collected at the entrance door of the appliance are injected in a single movement. This procedure will be done before and immediately after treatment.	Through study completion, an average of 1 year.
Secondary	Microbiological analysis of tongue coating	The microbiological analysis of tongue coating will be performed by collecting biofilm samples from the region of the lingual dorsum with a 1µl inoculation loop. Samples will be transferred into individual vials containing 1.5 ml of reduced transport fluid and vortexed for approximately 30 seconds. After homogenisation, the ten-fold dilution series will be prepared in 180µl sterile PBS solution and 10-2, 10-3, 10-4 and 10-5 aliquots, transferred to BHI agar plates. Considering that the main bacteria responsible for the production of CSV are Gram-negative and anaerobic, plaques will be incubated in an anaerobic jar for 72 h at 370 C, for counting of the colony-forming units (CFU) and comparison of the numbers before and immediately after treatment.	Through study completion, an average of 1 year.