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临床试验/NCT03996915
NCT03996915已完成不适用

Evaluation of Halitosis in Adult Patients After Treatment With Photodynamic Therapy Associated With Periodontal Treatment: Protocol for a Randomized, Controlled Single Blinded Trial With 3-month Follow up

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
halitosis measurement (gas chromatography test)

研究概览

简要总结

The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy or G2-cleaning of the tongue with a tongue scraper . Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola

详细描述

Halitosis is an unpleasant odor that emanating from the mouth. A recent metanalysis shows worldwide trend towards a rise in halitosis prevalence. Studies show halitosis returns in a week after treatment with photodynamic therapy (PDT). Probably, bacteria residing in the periodontal sulcus could recolonize the dorsum of the tongue. To date, there are no study in adult population that associate halitosis and periodontal treatment with follow-up evaluation. The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants (n=40) with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20). Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola. The evaluation of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and three months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile (OHIP-14) Comparisons will be made with ANOVA test, with the level of significance of 5 %. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults.

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)

盲法说明

single blind

入排标准

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

入选标准

  • Both genders
  • with at least 10 teeth
  • Periodontal screening and recording (PSR) 0, 1 or 2
  • without any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
  • positive halitosis (SH2 level higher than 112 ppb).

排除标准

  • ex-smokers for less than 5 years
  • patients with hypersensitivity to the photosensitizer.

结局指标

主要结局

halitosis measurement (gas chromatography test)

时间窗: through study completion on average of one year

The portable Oral Chroma will be used for the assessment of halitosis. Oral air collection will follow the manufactured guide lines (Oral Chroma Manual Instruction). A syringe will be placed in the patient's mouth with the plunger completely inserted and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air. This procedure will be repeated. The gas injection needle will be placed on the syringe and the plunger will be adjusted to 0.5 ml. This air will be injected into the input of the device in a single motion. This procedure will be done before, immediately after PDT or scraper and after periodontal treatment.

次要结局

  • microbiological analysis(through study completion on average of one year)

研究者

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

Anna Carolina Ratto Tempestini Horliana

Phd, clinical professor

University of Nove de Julho

研究点 (2)

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