Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial

Introduction Halitosis is a term that defines any unpleasant odour smell originating from the oral cavity and may have a local or systemic origin. This project aims to determine the effectiveness of treatment involving antimicrobial photodynamic therapy (aPDT) combined with treatment using probiotic...

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Main Authors: Ana Paula Taboada Sobral, Marcela Leticia Leal Gonçalves, Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Sandra Kalil Bussadori, Juliana Maria Altavista Sagretti Gallo, Amanda Rafaelly Honório Mandetta, Renato Araujo Prates, Cinthya Cosme Gutierrez Duran, Caroline Diniz Pagani Vieira Ribeiro, Valherya Silva Rodriguez
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Language:English
Published: BMJ Publishing Group 2025-04-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/4/e095544.full
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author Ana Paula Taboada Sobral
Marcela Leticia Leal Gonçalves
Lara Jansiski Motta
Anna Carolina Ratto Tempestini Horliana
Kristianne Porta Santos Fernandes
Raquel Agnelli Mesquita-Ferrari
Sandra Kalil Bussadori
Juliana Maria Altavista Sagretti Gallo
Amanda Rafaelly Honório Mandetta
Renato Araujo Prates
Cinthya Cosme Gutierrez Duran
Caroline Diniz Pagani Vieira Ribeiro
Valherya Silva Rodriguez
author_facet Ana Paula Taboada Sobral
Marcela Leticia Leal Gonçalves
Lara Jansiski Motta
Anna Carolina Ratto Tempestini Horliana
Kristianne Porta Santos Fernandes
Raquel Agnelli Mesquita-Ferrari
Sandra Kalil Bussadori
Juliana Maria Altavista Sagretti Gallo
Amanda Rafaelly Honório Mandetta
Renato Araujo Prates
Cinthya Cosme Gutierrez Duran
Caroline Diniz Pagani Vieira Ribeiro
Valherya Silva Rodriguez
author_sort Ana Paula Taboada Sobral
collection DOAJ
description Introduction Halitosis is a term that defines any unpleasant odour smell originating from the oral cavity and may have a local or systemic origin. This project aims to determine the effectiveness of treatment involving antimicrobial photodynamic therapy (aPDT) combined with treatment using probiotics at reducing halitosis.Methods and analysis 92 individuals from 18 to 60 years of age with a diagnosis of halitosis (sulfide≥112 ppb, gas chromatography) will be selected. The participants will be randomly allocated to four groups (n=23). Group 1 (control): brushing, dental floss and tongue scraper; group 2: brushing, dental floss, tongue scraper and aPDT with blue Light Emitting Diode (LED) +annatto; group 3: brushing, dental floss, tongue scraper and aPDT with blue Light Emitting Diode (LED) +annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12); and group 4: brushing, dental floss, tongue scraper and probiotic lozenges containing S. salivarius K12 (BLIS K12). Comparisons will be made of the respiratory analysis results before and immediately after the first treatment session, at the end of the 30-day treatment period and again 60 days after the treatment initiation. Microbiological analysis (counts of colony-forming units of viable bacteria from coated tongue) will be performed at the same time. The microbiome analysis will be conducted before treatment, 30 days after treatment completion and 60 days after treatment initiation, following DNA extraction. All groups will receive oral hygiene instructions as well as brushes, toothpaste and dental floss. Data normality will be checked using Shapiro-Wilk test. In the case of normality, analysis of variance is used for the comparisons. In the case of non-parametric data, Kruskal-Wallis test will be used. Wilcoxon test will be used to analyse the results of each treatment between two assessment times.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 82830524.6.0000.5511; approval date: 2 October 2024). Participants will agree to take part in the study by signing an informed consent form. The findings will be published in a peer-reviewed journal. The collected data will be available in the OSF data repository.Trial registration number NCT06583720.
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spelling doaj-art-bb9d69087db540a2966d25909aa79cb82025-08-20T03:52:11ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-095544Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trialAna Paula Taboada Sobral0Marcela Leticia Leal Gonçalves1Lara Jansiski Motta2Anna Carolina Ratto Tempestini Horliana3Kristianne Porta Santos Fernandes4Raquel Agnelli Mesquita-Ferrari5Sandra Kalil Bussadori6Juliana Maria Altavista Sagretti Gallo7Amanda Rafaelly Honório Mandetta8Renato Araujo Prates9Cinthya Cosme Gutierrez Duran10Caroline Diniz Pagani Vieira Ribeiro11Valherya Silva Rodriguez12Postgraduation Program in Health and Environment, Universidade Metropolitana de Santos, Santos, BrazilPostgraduation Program in Health and Environment, Universidade Metropolitana de Santos, Santos, BrazilPostgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilPostgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilPostgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilPostgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilPostgraduate Programme in Rehabilitation Sciences, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, Brazil, São Paulo, BrazilPostgraduation Program in Veterinary Medicine in the Coastal Environment, Universidade Metropolitana de Santos, Santos, BrazilPostgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilPostgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Campus Vergueiro, São Paulo, SP, BrazilPostgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilPostgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilUndergraduate Program in Biomedical Science, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, BrazilIntroduction Halitosis is a term that defines any unpleasant odour smell originating from the oral cavity and may have a local or systemic origin. This project aims to determine the effectiveness of treatment involving antimicrobial photodynamic therapy (aPDT) combined with treatment using probiotics at reducing halitosis.Methods and analysis 92 individuals from 18 to 60 years of age with a diagnosis of halitosis (sulfide≥112 ppb, gas chromatography) will be selected. The participants will be randomly allocated to four groups (n=23). Group 1 (control): brushing, dental floss and tongue scraper; group 2: brushing, dental floss, tongue scraper and aPDT with blue Light Emitting Diode (LED) +annatto; group 3: brushing, dental floss, tongue scraper and aPDT with blue Light Emitting Diode (LED) +annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12); and group 4: brushing, dental floss, tongue scraper and probiotic lozenges containing S. salivarius K12 (BLIS K12). Comparisons will be made of the respiratory analysis results before and immediately after the first treatment session, at the end of the 30-day treatment period and again 60 days after the treatment initiation. Microbiological analysis (counts of colony-forming units of viable bacteria from coated tongue) will be performed at the same time. The microbiome analysis will be conducted before treatment, 30 days after treatment completion and 60 days after treatment initiation, following DNA extraction. All groups will receive oral hygiene instructions as well as brushes, toothpaste and dental floss. Data normality will be checked using Shapiro-Wilk test. In the case of normality, analysis of variance is used for the comparisons. In the case of non-parametric data, Kruskal-Wallis test will be used. Wilcoxon test will be used to analyse the results of each treatment between two assessment times.Ethics and dissemination This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 82830524.6.0000.5511; approval date: 2 October 2024). Participants will agree to take part in the study by signing an informed consent form. The findings will be published in a peer-reviewed journal. The collected data will be available in the OSF data repository.Trial registration number NCT06583720.https://bmjopen.bmj.com/content/15/4/e095544.full
spellingShingle Ana Paula Taboada Sobral
Marcela Leticia Leal Gonçalves
Lara Jansiski Motta
Anna Carolina Ratto Tempestini Horliana
Kristianne Porta Santos Fernandes
Raquel Agnelli Mesquita-Ferrari
Sandra Kalil Bussadori
Juliana Maria Altavista Sagretti Gallo
Amanda Rafaelly Honório Mandetta
Renato Araujo Prates
Cinthya Cosme Gutierrez Duran
Caroline Diniz Pagani Vieira Ribeiro
Valherya Silva Rodriguez
Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial
BMJ Open
title Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial
title_full Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial
title_fullStr Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial
title_full_unstemmed Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial
title_short Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial
title_sort comparative study of photodynamic therapy with led and probiotics in the treatment of halitosis protocol for a randomised controlled clinical trial
url https://bmjopen.bmj.com/content/15/4/e095544.full
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