Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis

Официальное название

Comparative Study Between Photodynamic Therapy with LED Associated with Probiotics in the Treatment of Halitosis - Controlled Randomized Clinical Trial

Обзор

Halitosis is a term that defines any odor or bad smell coming from the oral cavity, which can have a local or systemic origin. This project aims to verify if there is a difference in the effectiveness of treatment with antimicrobial photodynamic therapy (aPDT) with LED associated with treatment using probiotics in reducing halitosis. 92 participants, aged 18 to 60 years, diagnosed with halitosis, presenting sulfhydride (SH2) ≥ 112 ppb in gas chromatography will be selected. Participants will be randomly divided into 4 groups (n=23), which will receive different treatments: Group 1 (control): brushing, dental floss and tongue scraper; Group 2: brushing, dental floss, tongue scraper and aPDT with blue LED and annatto; Group 3: brushing, dental flossing, tongue scraper and aPDT with blue LED, annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®); Group 4: brushing, dental flossing, tongue scraper and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®). The results of the halimetry will be compared before, immediately after the treatments, thirty days after and sixty days after. The microbiological analysis will be performed by counting the colony forming unit of viable bacteria in the tongue coating at these same times. The microbiome analysis will be performed before, thirty days after and sixty days after the treatments after DNA extraction. All groups will be treated with oral hygiene instructions with a toothbrush, toothpaste and dental floss as well as receiving material for this practice. The normality of the data will be measured by the Shapiro-Wilk test, and in the case of normality the Analysis of Variance (ANOVA) test will be applied, and in the case of non-parametric data, the Kruskal-Wallis test will be used. The Wilcoxon test will be used to analyze the results of each treatment in the two study periods.

Вмешательства

• Процедура Oral hygiene at home
  Participant will be taught on how to correctly brush their teeth, use dental floss and scrape their tongues at home.
• Процедура aPDT
  A weekly aPDT session will be performed for a period of 30 days, with the photosensitizer (PS) annatto manipulated at a concentration of 20% (Fórmula e Ação®). 2 ml (quantity measured with a pipette) will be applied to the middle third and dorsum of the tongue for 2 minutes for incubation (pre-irradiation time). The excess will be removed with a suction device in order to keep the surface moist with the PS itself. Six points will be irradiated with a distance of 1 cm between them, considering th
• Пищевая добавка Probiotics
  Probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®) (OralBiotic; Master Products, Fort Lauderdale, Florida, United States) will be used. Each patient will receive 60 lozenges, which should be allowed to dissolve slowly and completely in the mouth. Patients are instructed to use the lozenges twice a day for a period of 30 days.

Первичные конечные точки

• Changes in Halimetry Levels [Срок оценки: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.]

Вторичные конечные точки (2)

• Changes in Microbiological Analysis [Срок оценки: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.]
• Changes in Microbiome Analysis [Срок оценки: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.]

Критерии участия

Критерии включения

• Diagnosis of halitosis showing sulfhydride (SH2) ≥ 112 ppb in gas chromatography.

Критерии исключения

• Individuals with dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
• Undergoing orthodontic and/or orthopedic treatment;
• Undergoing oncological treatment;
• With systemic alterations (gastrointestinal, renal, hepatic)
• Undergoing antibiotic treatment up to 1 month before the research;
• Pregnant women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Nove de Julho University — São Paulo

Публикации

• Mandetta ARH, Gallo JMAS, Ribeiro CDPV, Goncalves MLL, Sobral APT, Motta LJ, Horliana ACRT, Mesquita-Ferrari RA, Rodriguez VS, Prates RA, Duran CCG, Fernandes KPS, Bussadori SK. Comparative study of photodynamic therapy with LED and probiotics in the treatment of halitosis: protocol for a randomised controlled clinical trial. BMJ Open. 2025 Apr 25;15(4):e095544. doi: 10.1136/bmjopen-2024-095544. PMID 40280606

Идентификаторы

NCT: NCT06583720 · HaliFAPESP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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