- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03346460
Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis
May 1, 2018 updated by: Marcela Leticia Leal Gonçalves, University of Nove de Julho
Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis: a Clinical and Microbiological Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marcela LL Gonçalves, MS
- Phone Number: +55113385-9010
- Email: marcelalleal@hotmail.com
Study Contact Backup
- Name: Sandra K Bussadori, PhD
- Phone Number: +55113385-9010
- Email: sandra.skb@gmail.com
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01504-001
- Recruiting
- UniNove
-
Contact:
- Marcela LL Gonçalves, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
EXPERIMENTAL: 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.
|
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.
|
EXPERIMENTAL: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Halimetry (gas chromatography)
Time Frame: Through study completion, an average of 1 year.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiological analysis of tongue coating
Time Frame: Through study completion, an average of 1 year.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marcela LL Gonçalves, MS, University of Nove de Julho
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 5, 2018
Primary Completion (ANTICIPATED)
December 5, 2018
Study Completion (ANTICIPATED)
December 5, 2018
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
November 15, 2017
First Posted (ACTUAL)
November 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 4, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HALIURU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Halitosis
-
Hadassah Medical OrganizationCompleted
-
Semmelweis UniversityNot yet recruiting
-
University of North Carolina, Chapel HillColgate PalmoliveCompletedHalitosisUnited States
-
Novozymes A/SCompleted
-
Riyadh Colleges of Dentistry and PharmacyUnknown
-
Cairo UniversityUnknown
-
Universitaire Ziekenhuizen KU LeuvenGaba International AGUnknown
-
Okayama UniversityCompleted
-
Tokyo Medical and Dental UniversityCompleted
Clinical Trials on Tongue Scraping
-
UConn HealthCompletedOral Hygiene | HalitosisUnited States
-
University of Nove de JulhoCompleted
-
University of Nove de JulhoCompleted
-
The Hong Kong Polytechnic UniversityMassachusetts General HospitalCompleted
-
Siesta Medical, Inc.Terminated
-
Shahid Beheshti University of Medical SciencesCompletedMaxillary DeficiencyIran, Islamic Republic of
-
First Affiliated Hospital of Wenzhou Medical UniversityCompletedLiver Diseases | Small Bowel Disease | Colorectal Disease | Gastric Diseases | Digestive Tract DiseasesChina
-
Sleepy, IncTerminatedSnoring | Obstructive Sleep ApneaAustralia, United States
-
University of South FloridaTexas Christian University; Loma Linda University; James Madison UniversityUnknown