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

Primary Purpose

Halitosis

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Tongue Scraping
aPDT
Tongue scraper and aPDT
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UNINOVERecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Tongue scraper group (Group 1)

aPDT group (Group 2)

Tongue scraper and aPDT (Group 3)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 15, 2017
Last Updated
May 1, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03346460
Brief Title
Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis
Official Title
Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis: a Clinical and Microbiological Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
December 5, 2018 (Anticipated)
Study Completion Date
December 5, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tongue scraper group (Group 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
aPDT group (Group 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Tongue scraper and aPDT (Group 3)
Arm Type
Experimental
Arm Description
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
Other
Intervention Name(s)
Tongue Scraping
Intervention Description
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
Radiation
Intervention Name(s)
aPDT
Intervention Description
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
Intervention Name(s)
Tongue scraper and aPDT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Halimetry (gas chromatography)
Description
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.
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Microbiological analysis of tongue coating
Description
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.
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcela LL Gonçalves, MS
Phone
+55113385-9010
Email
marcelalleal@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra K Bussadori, PhD
Phone
+55113385-9010
Email
sandra.skb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcela LL Gonçalves, MS
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNINOVE
City
São Paulo
State/Province
SP
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcela LL Gonçalves, MS

12. IPD Sharing Statement

Citations:
PubMed Identifier
30373650
Citation
Goncalves MLL, da Mota ACC, Deana AM, Guedes GH, Cavalcante LAS, Prates RA, Horliana ACRT, Pavani C, Motta LJ, Bitencourt GB, Fernandes KPS, Salgueiro MDCC, Mesquita-Ferrari RA, da Silva DFT, Franca CM, Bussadori SK. Photodynamic therapy with Bixa orellana extract and LED for the reduction of halitosis: study protocol for a randomized, microbiological and clinical trial. Trials. 2018 Oct 29;19(1):590. doi: 10.1186/s13063-018-2913-z.
Results Reference
derived

Learn more about this trial

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

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