Effect of Photodymamic Therapy With Urucum and LED in the Reduction of Halitosis
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2018
CompletedMay 4, 2018
May 1, 2018
9 months
November 15, 2017
May 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Microbiological analysis of tongue coating
Through study completion, an average of 1 year.
Study Arms (3)
Tongue scraper group (Group 1)
EXPERIMENTALFifteen 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.
aPDT group (Group 2)
EXPERIMENTALFifteen 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 scraper and aPDT (Group 3)
EXPERIMENTALTongue 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
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.
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.
Eligibility Criteria
You may qualify if:
- Age between 18 and 25 years;
- Sulphide (SH2) ≥ 112 ppb in the gas chromatography.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNINOVE
São Paulo, São Paulo, 01504-001, Brazil
Related Publications (1)
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.
PMID: 30373650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcela LL Gonçalves, MS
University of Nove de Julho
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 15, 2017
First Posted
November 17, 2017
Study Start
March 5, 2018
Primary Completion
December 5, 2018
Study Completion
December 5, 2018
Last Updated
May 4, 2018
Record last verified: 2018-05