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临床试验/NCT06583720
NCT06583720招募中1 期

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

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
92
试验地点
1
主要终点
Changes in Halimetry Levels

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Control group

Experimental

Participants in this group will perform brushing, dental floss and tongue scraper.

干预措施: Oral hygiene at home (Procedure)

aPDT group

Experimental

Participants in this group will receive brushing, dental floss, tongue scraper and aPDT with blue LED and annatto.

干预措施: Oral hygiene at home (Procedure)

aPDT group

Experimental

Participants in this group will receive brushing, dental floss, tongue scraper and aPDT with blue LED and annatto.

干预措施: aPDT (Procedure)

aPDT and Probiotics group

Experimental

Participants in this group will receive brushing, dental floss, lingual scraper and aPDT with blue LED, annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).

干预措施: Oral hygiene at home (Procedure)

aPDT and Probiotics group

Experimental

Participants in this group will receive brushing, dental floss, lingual scraper and aPDT with blue LED, annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).

干预措施: aPDT (Procedure)

aPDT and Probiotics group

Experimental

Participants in this group will receive brushing, dental floss, lingual scraper and aPDT with blue LED, annatto and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).

干预措施: Probiotics (Dietary Supplement)

Probiotics group

Experimental

Participants in this group will receive brushing, dental floss, lingual scraper and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).

干预措施: Oral hygiene at home (Procedure)

Probiotics group

Experimental

Participants in this group will receive brushing, dental floss, lingual scraper and probiotic lozenges containing Streptococcus salivarius K12 (BLIS K12®).

干预措施: Probiotics (Dietary Supplement)

结局指标

主要结局

Changes in Halimetry Levels

时间窗: Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.

The collection of oral air will follow the manufacturer\'s instructions (Oral ChromaTM Manual Instruction), where the participant will be instructed to rinse with cysteine (10 mM) for 1 minute, then keep their mouth closed for another minute. A syringe from the same manufacturer, suitable for collecting oral air, will be placed in the patient\'s mouth. For 1 minute, the patient will remain with their mouth closed, breathing through their nose, without touching the syringe with their tongue. The plunger will be pulled out, we will empty the air from the syringe into the patient\'s mouth again and pull the plunger again to fill the syringe with the breath sample. We will clean the tip of the syringe with gauze to remove moisture from the saliva, place the gas injection needle on the syringe, and adjust the plunger to 0.5 ml. The collected gases are injected into the inlet port of the device with a single movement.

次要结局

  • Changes in Microbiological Analysis(Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.)
  • Changes in Microbiome Analysis(Baseline, immediately after treatment, 30 days after treatment and 60 days after treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Kalil Bussadori

Principal Investigator

University of Nove de Julho

研究点 (1)

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