Action of Antimicrobial Photodynamic Therapy With Red Leds in Microorganisms Related to Halitose: Clinical Controlled and Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Clinical Results after treatment with gás chromatography
研究概览
简要总结
Halitosis is the term used to describe any unpleasant odor relative to expired air regardless of its source. The prevalence of halitosis in the population is approximately 30%, of which 80-90% of the cases originate in the oral cavity resulting from proteolytic degradation by gram negative anaerobic bacteria. Antimicrobial photodynamic therapy (aPDT) has been widely used and with very satisfactory results in the health sciences, it involves the use of a non-toxic dye, called photosensitizer (FS), and a light source of a specific wavelength in the presence of the oxygen in the medium. This interaction, is capable of creating toxic species that generate cell death. The advantages of this approach are to avoid resistance to target bacteria and damage to adjacent tissues as the antimicrobial effect is confined only to areas covered by the dye and irradiated by light acting on the target organism rapidly, depending on the dose of light energy and power output. The objective of this controlled clinical study is to verify the effect of aPDT in the treatment of halitosis by evaluating the formation of volatile sulfur compounds with gas chromatography and microbiological analysis before and after treatment. Will be included in this research young adults in the age group between 18 to 25 years with diagnosis of halitosis. The selected subjects will be divided into 3 groups, G1 aPDT, G2 Scraper and G3 aPDT and scraper. All subjects will be submitted to microbiological analysis and evaluation with Oral ChromaTM before, after treatment and followed up of 7, 14 and 30 days For the evaluation of the association of the categorical variables will be used Chi-square test and Fisher's Exact Test, to compare the means will be used tStudent test and Analysis of variance (ANOVA) and to analyze the correlation between the continuous variables will be applied the correlation test by Pearson. In the analyzes of the experimental differences in each group the Wilcoxon test will be used. For all analyzes a level of significance of 95% (p <0.05) will be considered.
详细描述
The study will follow the regulatory norms of research in humans with favorable opinion of the Research Ethics Committee of the University Nove de Julho number, and the responsible ones of the participants will sign the consent form free after clarifications for authorization of the participation in the research, according to Resolution 466/12 of the National Health Council.
Type of study: A controlled, quantitative cross-sectional clinical study. Hypothesis Null hypothesis: There is no alteration of halitosis after the use of photodynamic therapy employing the use of blue dye and red LED.
There is no microbiological alteration after antimicrobial photodynamic therapy.
Experimental hypothesis: There is a decrease in halitosis after the use of photodynamic therapy using blue dye and red LED associated or not with the tongue scraper.
There is microbiological alteration after antimicrobial photodynamic therapy.
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
- •Included in this study are young adults between the ages of 18 and 25, with an informed consent form and authorization for the diagnosis and treatment of halitosis.
- •Young adults diagnosed with halitosis presenting Oralchroma S2H ≥ 112 ppb and / or CH3SH ≥ 26.
排除标准
- •With dentofacial anomalies,
- •In orthodontic and / or orthopedic treatment,
- •Using a removable device, implant and / or prosthesis,
- •With periodontal disease,
- •With teeth with carious lesions,
- •In cancer treatment,
- •On antibiotic treatment up to 1 month prior to the survey,
- •Pregnant,
- •With hypersensitivity to the photosensitizer to be used.
研究组 & 干预措施
aPDT group
For photodynamic therapy will be used an equipment developed for this project with emission of red LED (660nm) and tip of 2.84 cm² .One session of the Chimiolux® photosensitizing aPDT will be performed, at a concentration of 0.005%, to be applied enough to cover the middle third and back of the tongue for 2 minutes for incubation. Four points will be irradiated with a distance of 1cm between the points, considering the scattering halo and the effectiveness of aPDT. The LED apparatus will be previously calibrated with wavelength 660 nm, with energy of 72 J, power of 800 mW for 90 seconds per point, creep of 282mW / cm².
干预措施: photodynamic therapy (Procedure)
Tongue Scraper
Tongue scraper 10 times in the tongue, from the back to the front.
干预措施: Tongue scraper (Procedure)
aPDT and tongue scraper
Tongue scraper 10 times in the tongue, from the back to the front. For aPDT will be used an equipment developed for this project with emission of red LED (660nm) and tip of 2.84 cm² . One session of the Chimiolux® photosensitizing aPDT will be performed, at a concentration of 0.005%, to be applied enough to cover the middle third and back of the tongue for 2 minutes for incubation. Four points will be irradiated with a distance of 1cm between the points. Based on previous studies carried out with the aPDT for the treatment of halitosis the apparatus will be previously calibrated with wavelength 660 nm, with energy of 72 J, power of 800 mW for 90 seconds per point, creep of 282mW / cm².
干预措施: photodynamic therapy (Procedure)
aPDT and tongue scraper
Tongue scraper 10 times in the tongue, from the back to the front. For aPDT will be used an equipment developed for this project with emission of red LED (660nm) and tip of 2.84 cm² . One session of the Chimiolux® photosensitizing aPDT will be performed, at a concentration of 0.005%, to be applied enough to cover the middle third and back of the tongue for 2 minutes for incubation. Four points will be irradiated with a distance of 1cm between the points. Based on previous studies carried out with the aPDT for the treatment of halitosis the apparatus will be previously calibrated with wavelength 660 nm, with energy of 72 J, power of 800 mW for 90 seconds per point, creep of 282mW / cm².
干预措施: Tongue scraper (Procedure)
结局指标
主要结局
Clinical Results after treatment with gás chromatography
时间窗: 30 days
If halitosis reduces in patients after treatment
次要结局
- Microbiological Analysis after treatment with qPCR analisys(30 days)
研究者
Ana Carolina Costa da Mota
Clinical Professor
University of Nove de Julho