Toluidin Blue Orto-mediated Antimicrobial Photodynamic Therapy or Lingual Scraper Associated With Periodontal Treatment in the Reduction of Halitosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Total number of microorganisms
研究概览
简要总结
The aim of this study is to compare the effectiveness of two methods of treating bad breath. Patients are enrolled in the study based on an objective test using the Oral Chroma device, which measures the concentration of volatile sulfur compounds in exhaled air, which are responsible for bad breath. Before the test begins, a sample will also be taken from the tongue to determine the total number of microorganisms. Patients are then randomly assigned to two groups.
Group 1 (control): cleaning the tongue with a tongue scraper and rinsing the mouth with an antiseptic mouthwash.
Group two (intervention): cleaning the tongue with a tongue scraper and antibacterial laser therapy on the tongue.
Then, all study participants will undergo a procedure to clean tartar from all their teeth.
Questions to be answered by the study: Will there be a decrease in the concentration of volatile sulfur compounds in exhaled air after treatment? Will the treatment results obtained after laser therapy be better compared to the classic method of treating bad breath? Cleaning procedures within the tongue will be performed at the beginning, then repeated after 1 week, two weeks, and 3 months.
After each stage, the concentration of substances in exhaled air that are responsible for bad breath will be measured. Samples will be taken from the tongue to determine the total number of microorganisms before the first tongue cleaning, and then after 2 weeks.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with halitosis based on an objective exhaled sulfhydryl (H2S) concentration of ≥ 112 ppb (1.5 ng/10 mL) determined by gas chromatography (Oral Chroma) and who signed an informed consent form previously approved by the Bioethics Committee were included in the study.
排除标准
- •The study excluded patients with a history of the following diseases:
- •otolaryngological, i.e., chronic tonsillitis (presence of tonsil plugs), chronic sinusitis, head and neck cancer
- •gastrointestinal, i.e., Helicobacter Pylori infection, esophageal diverticulitis, pyloric sphincter insufficiency, severe gastroesophageal reflux disease
- •pulmonary, i.e., bronchitis, bronchiectasis, lung cancer - metabolic, i.e., diabetes, uremia, chronic renal failure, and liver disease as well as individuals taking pharmacotherapies such as antihistamines, steroids, anticholinergics, antispasmodics, alcohol consumers, smokers, and those suffering from severe obesity.
- •on antibiotic or antifungals treatment up to 1 month before the survey,
- •pregnant Additinaly indyviduals with local abnormalities were excluded: using a removable device, implant and/or prosthesis, with carious lesions, during orthodontic and/or orthopedic treatment, with hypersensitivity to the photosensitizer to be used.
研究组 & 干预措施
control group
干预措施: full mouth scaling (Procedure)
study group
干预措施: Tongue scraper and aPDT (photodynamic therapy) (Procedure)
study group
干预措施: full mouth scaling (Procedure)
control group
干预措施: Tongue scraper and oral rinse treatment (Procedure)
结局指标
主要结局
Total number of microorganisms
时间窗: Before first intervention, after 2 weeks.
Swab samples were collected from the dorsum of the tongue (posterior third). The material collected from the tongue was inoculated separately onto the Rodac ConTact Test to determine the total number of microorganisms.
Values of concentration of VSCs (volatile sulfur compounds) in exhaled air
时间窗: before and after first intervention, after one week, after two weeks, after 3 months
Values of concentration of VSCs above 112 ppb (1.5 ng/10 mL) were indicators of halitosis.
次要结局
未报告次要终点