Clinical trial NCT03346460: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Halitosis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Halimetry (gas chromatography)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Microbiological analysis of tongue coating
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UNINOVE
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Marcela LL Gonçalves, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.