Mandetta Amanda Rafaelly Honório, Gallo Juliana Maria Altavista Sagretti, Ribeiro Caroline Diniz Pagani Vieira, Gonçalves Marcela Letícia Leal, Sobral Ana Paula Taboada, Motta Lara Jansiski, Horliana Anna Carolina Ratto Tempestini, Mesquita-Ferrari Raquel Agnelli, Rodriguez Valherya Silva, Prates Renato Araujo, Duran Cinthya Cosme Gutierrez, Fernandes Kristianne Porta Santos, Bussadori Sandra Kalil
Postgraduation Program in Medicine Biophotonics, Universidade Nove de Julho, Campus Vergueiro, Sao Paulo, Brazil.
Postgraduation Program in Veterinary Medicine in the Coastal Environment, Universidade Metropolitana de Santos, Santos, Brazil.
BMJ Open. 2025 Apr 25;15(4):e095544. doi: 10.1136/bmjopen-2024-095544.
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.
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 K12 (BLIS K12); and group 4: brushing, dental floss, tongue scraper and probiotic lozenges containing 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.
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.
NCT06583720.
口臭是一个定义源自口腔的任何不愉快气味的术语，其可能有局部或全身来源。本项目旨在确定抗菌光动力疗法（aPDT）联合益生菌治疗在减轻口臭方面的有效性。
将选取92名年龄在18至60岁之间、诊断为口臭（硫化物≥112 ppb，气相色谱法）的个体。参与者将被随机分配到四组（n = 23）。第1组（对照组）：刷牙、使用牙线和舌刷；第2组：刷牙、使用牙线、舌刷以及用蓝色发光二极管（LED）+胭脂树进行的aPDT；第3组：刷牙、使用牙线、舌刷以及用蓝色发光二极管（LED）+胭脂树进行的aPDT和含K12（BLIS K12）的益生菌含片；第4组：刷牙、使用牙线、舌刷以及含K12（BLIS K12）的益生菌含片。将对首次治疗 session 前、首次治疗 session 后即刻、30天治疗期结束时以及治疗开始后60天的呼吸分析结果进行比较。同时将进行微生物学分析（对舌苔上活细菌的菌落形成单位计数）。微生物组分析将在治疗前、治疗完成后30天以及治疗开始后60天进行，在DNA提取之后。所有组都将接受口腔卫生指导以及牙刷、牙膏和牙线。将使用Shapiro-Wilk检验检查数据正态性。在数据呈正态分布的情况下，使用方差分析进行比较。在数据为非参数数据的情况下，将使用Kruskal-Wallis检验。将使用Wilcoxon检验分析两个评估时间点之间每种治疗的结果。
本方案已获七月九日大学人类研究伦理委员会批准（证书编号：82830524.6.0000.5511；批准日期：2024年10月2日）。参与者将通过签署知情同意书同意参与本研究。研究结果将发表在同行评审期刊上。所收集的数据将在开放科学框架（OSF）数据存储库中提供。
NCT06583720。
