Comparative Study Between Photodynamic Therapy Using Urucum + LED and Probiotics in Halitosis Reduction - Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in halimetry (gas chromatography)
研究概览
简要总结
Introduction: Halitosis is a term that defines any foul odor emanating from the oral cavity. The origin may be local or systemic. The aim of the proposed project is to determine whether treatment with antimicrobial photodynamic therapy (aPDT) and treatment with probiotics are effective at eliminating halitosis. Methods and analysis: Fifty-two patients from 18 to 25 years old with a diagnosis of halitosis (H2S≥112 ppb determined by gas chromatography) will be randomly allocated to four groups (n=13) who will receive different treatments: Group 1 - treatment with teeth brushing, dental floss and tongue scraper; Group 2 - brushing, dental floss and aPDT; Group 3 - brushing, dental floss and probiotics; Group 4 - brushing, flossing, aPDT and probiotics. The results of the halimeter testing will be compared before, immediately after, seven days and thirty days after treatment. The microbiological analysis of the coated tongue will be performed at these same times. The quantitative analysis will be conducted using real-time PCRq. The normality of the data will be determined using the Shapiro-Wilk test. Data with normal distribution will be analyzed using analysis of variance (ANOVA). Non-parametric data will be analyzed using the Kruskal-Wallis test. The Wilcoxon test will be used to analyze the results of each treatment at the different evaluation periods. Ethics and dissemination: This study has been approved by the Ethics Committee of UNINOVE under process number 3.669.442. Results will be published in peer-reviewed journals and will be presented at national and international conferences.
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 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 25 years;
- •Sulphide (SH2) ≥ 112 ppb in the gas chromatography.
排除标准
- •Dentofacial anomalies (such as cleft lip and cleft palate);
- •Undergoing orthodontic and/or orthopedic treatment;
- •Undergoing oncological treatment;
- •Systemic alterations (gastrointestinal, renal, hepatic);
- •Treatment with antibiotics up to 1 month before the survey;
- •Pregnant.
- •Individuals with fissured tongue
研究组 & 干预措施
Group 1
Thirteen patients who will receive treatment with teeth brushing, dental floss and tongue scraper.
干预措施: Teeth brushing and flossing (Other)
Group 1
Thirteen patients who will receive treatment with teeth brushing, dental floss and tongue scraper.
干预措施: Tongue scraping (Other)
Group 2
Thirteen patients who will receive treatment with teeth brushing, dental floss and antimicrobial photodynamic therapy applied to the back and middle third of the tongue.
干预措施: Teeth brushing and flossing (Other)
Group 2
Thirteen patients who will receive treatment with teeth brushing, dental floss and antimicrobial photodynamic therapy applied to the back and middle third of the tongue.
干预措施: Antimicrobial Photodynamic Therapy (aPDT) (Radiation)
Group 3
Thirteen patients who will receive treatment with teeth brushing, dental floss and probiotics.
干预措施: Teeth brushing and flossing (Other)
Group 3
Thirteen patients who will receive treatment with teeth brushing, dental floss and probiotics.
干预措施: Probiotics (Biological)
Group 4
Thirteen patients who will receive treatment with teeth brushing, dental floss, antimicrobial photodynamic therapy applied to the back and middle third of the tongue and probiotics..
干预措施: Teeth brushing and flossing (Other)
Group 4
Thirteen patients who will receive treatment with teeth brushing, dental floss, antimicrobial photodynamic therapy applied to the back and middle third of the tongue and probiotics..
干预措施: Antimicrobial Photodynamic Therapy (aPDT) (Radiation)
Group 4
Thirteen patients who will receive treatment with teeth brushing, dental floss, antimicrobial photodynamic therapy applied to the back and middle third of the tongue and probiotics..
干预措施: Probiotics (Biological)
结局指标
主要结局
Change in halimetry (gas chromatography)
时间窗: Baseline, immediately after treatment, 7 days and 30 days after treatment.
Oral air collection will follow the manufacturer's guidelines (Oral ChromaTM Manual Instruction) where the participant will be instructed to rinse with cysteine (10 mM) for 1 minute, then remain with his/her mouth closed for 1 minute. A syringe from the same manufacturer for collection of mouth air will be introduced into the patient's mouth. During 1 minute the patient will remain closed mouth, breathing through the nose, without touching the syringe with the tongue. The plunger will be pulled out, we will re-empty the syringe air into the patient's mouth and again pull the plunger to fill the syringe with the breath sample. We will wipe the tip of the syringe with gauze to remove moisture from the saliva, place the gas injection needle in the syringe, and adjust the plunger to 0.5 ml. The gases collected at the entrance door of the appliance are injected in a single movement.
次要结局
- Change in microbiological analysis of tongue coating(Baseline, immediately after treatment, 7 days and 30 days after treatment.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho