Photodynamic Therapy With Red Leds in Microorganisms Related to Halitosis

NCT03656419 | Unknown

• 1 other identifier: Halitose
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Halitosis is the term used to describe any unpleasant odor relative to expired air regardless of its source. The prevalence of halitosis in the population is approximately 30%, of which 80-90% of the cases originate in the oral cavity resulting from proteolytic degradation by gram negative anaerobic bacteria. Antimicrobial photodynamic therapy (aPDT) has been widely used and with very satisfactory results in the health sciences, it involves the use of a non-toxic dye, called photosensitizer (FS), and a light source of a specific wavelength in the presence of the oxygen in the medium. This interaction, is capable of creating toxic species that generate cell death. The advantages of this approach are to avoid resistance to target bacteria and damage to adjacent tissues as the antimicrobial effect is confined only to areas covered by the dye and irradiated by light acting on the target organism rapidly, depending on the dose of light energy and power output. The objective of this controlled clinical study is to verify the effect of aPDT in the treatment of halitosis by evaluating the formation of volatile sulfur compounds with gas chromatography and microbiological analysis before and after treatment. Will be included in this research young adults in the age group between 18 to 25 years with diagnosis of halitosis. The selected subjects will be divided into 3 groups, G1 aPDT, G2 Scraper and G3 aPDT and scraper. All subjects will be submitted to microbiological analysis and evaluation with Oral ChromaTM before, after treatment and followed up of 7, 14 and 30 days For the evaluation of the association of the categorical variables will be used Chi-square test and Fisher's Exact Test, to compare the means will be used tStudent test and Analysis of variance (ANOVA) and to analyze the correlation between the continuous variables will be applied the correlation test by Pearson. In the analyzes of the experimental differences in each group the Wilcoxon test will be used. For all analyzes a level of significance of 95% (p \<0.05) will be considered.

Conditions

Halitosis

Keywords

Halitosis; Photodynamic Therapy; qPCR

Outcome Measures

Primary Outcomes (1)

• Clinical Results after treatment with gás chromatography

  If halitosis reduces in patients after treatment

  30 days

Secondary Outcomes (1)

• Microbiological Analysis after treatment with qPCR analisys

  30 days

Study Arms (3)

aPDT group

EXPERIMENTAL

For photodynamic therapy will be used an equipment developed for this project with emission of red LED (660nm) and tip of 2.84 cm² .One session of the Chimiolux® photosensitizing aPDT will be performed, at a concentration of 0.005%, to be applied enough to cover the middle third and back of the tongue for 2 minutes for incubation. Four points will be irradiated with a distance of 1cm between the points, considering the scattering halo and the effectiveness of aPDT. The LED apparatus will be previously calibrated with wavelength 660 nm, with energy of 72 J, power of 800 mW for 90 seconds per point, creep of 282mW / cm².

Procedure: photodynamic therapy

Tongue Scraper

ACTIVE COMPARATOR

Tongue scraper 10 times in the tongue, from the back to the front.

Procedure: Tongue scraper

aPDT and tongue scraper

EXPERIMENTAL

Tongue scraper 10 times in the tongue, from the back to the front. For aPDT will be used an equipment developed for this project with emission of red LED (660nm) and tip of 2.84 cm² . One session of the Chimiolux® photosensitizing aPDT will be performed, at a concentration of 0.005%, to be applied enough to cover the middle third and back of the tongue for 2 minutes for incubation. Four points will be irradiated with a distance of 1cm between the points. Based on previous studies carried out with the aPDT for the treatment of halitosis the apparatus will be previously calibrated with wavelength 660 nm, with energy of 72 J, power of 800 mW for 90 seconds per point, creep of 282mW / cm².

Procedure: photodynamic therapy; Procedure: Tongue scraper

Interventions

photodynamic therapy PROCEDURE

aPDT with methylene blue and red led irradiation.

aPDT and tongue scraper; aPDT group

Tongue scraper PROCEDURE

Tongue scraper 10 times from de back to the top.

Tongue Scraper; aPDT and tongue scraper

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Included in this study are young adults between the ages of 18 and 25, with an informed consent form and authorization for the diagnosis and treatment of halitosis.
• Young adults diagnosed with halitosis presenting Oralchroma S2H ≥ 112 ppb and / or CH3SH ≥ 26.

You may not qualify if:

• With dentofacial anomalies,
• In orthodontic and / or orthopedic treatment,
• Using a removable device, implant and / or prosthesis,
• With periodontal disease,
• With teeth with carious lesions,
• In cancer treatment,
• On antibiotic treatment up to 1 month prior to the survey,
• Pregnant,
• With hypersensitivity to the photosensitizer to be used.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, 04106001, Brazil

RECRUITING

Related Publications (1)

• da Mota ACC, Goncalves MLL, Horliana ACRT, Deana AM, de Souza Cavalcante LA, Gomes AO, Mayer MPA, Suguimoto ESA, Fernandes KPS, Mesquita-Ferrari RA, Prates RA, Motta LJ, Bussadori SK. Effect of antimicrobial photodynamic therapy with red led and methylene blue on the reduction of halitosis: controlled microbiological clinical trial. Lasers Med Sci. 2022 Mar;37(2):877-886. doi: 10.1007/s10103-021-03325-x. Epub 2021 May 13.

  PMID: 33987732 DERIVED

MeSH Terms

Conditions

Halitosis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Sandra Bussadori, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Central Study Contacts

Ana Carolina Ciarcia, Mrs

CONTACT

5511979889199; ana_cmota@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: A controlled, quantitative cross-sectional clinical study.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: September 4, 2018
• Study Start: January 2, 2018
• Primary Completion: October 24, 2018
• Study Completion: December 10, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)