NCT03346460

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

Status unknown Phase 2 Last updated 4 May 2018

What this trial tests

Phase 2 trial testing Tongue Scraping in Halitosis in 45 participants. Status unknown.

Timeline

5 March 2018

Primary endpoint
5 December 2018

5 December 2018

Quick facts

Lead sponsor	University of Nove de Julho
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	5 March 2018
Primary completion	5 December 2018
Estimated completion	5 December 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Tongue Scraping
• aPDT
• Tongue scraper and aPDT

Conditions studied

• Halitosis — all drugs for Halitosis →

Sponsor

University of Nove de Julho

Who can join

Adults 18 to 25, any sex, with Halitosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for managing halitosis.
   Kumbargere Nagraj S, Eachempati P, Uma E, Singh VP, et al · · 2019 · cited 29× · PMID 31825092 · DOI 10.1002/14651858.cd012213.pub2
2. Photodynamic therapy with Bixa orellana extract and LED for the reduction of halitosis: study protocol for a randomized, microbiological and clinical trial.
   Gonçalves MLL, da Mota ACC, Deana AM, Guedes GH, et al · · 2018 · cited 8× · PMID 30373650 · DOI 10.1186/s13063-018-2913-z