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临床试验/NCT06764342
NCT06764342已完成不适用

Adjunctive Effect of Photodynamic Therapy on Halitosis

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
sulfur volatile compounds changes

研究概览

简要总结

The present study aims to evaluate bad breath in patients undergoing gingival treatment combined with tongue scraping and laser and to assess its potential benefits for both periodontal and microbiological condition. Firs patients will be selected among those who participated in a privies study. Additional patients will be also invited. They must have gum disease and bad breath. Treatments will be completed within 24 hours and oral samples will be collected with thin paper points. Bad breath will be evaluated by a professional and a specific gas machine.

详细描述

The present study aims to evaluate halitosis in patients undergoing non-surgical periodontal therapy [(Full-mouth disinfection (FMD) combined with tongue scraping and antimicrobial photodynamic therapy (aPDT), and to assess its potential benefits for both periodontal and microbiological condition. A pilot study will be performed with participants who took part almost 10 years ago in the study NCT02368678. They will be invited by phone contact. In addition, new participants will be recruited by convenience in dental clinics from the Federal University of Minas Gerais until completion of 20 participants per group. Individuals with stage III periodontitis and halitosis (organoleptic method > 2), will be allocated into two periodontal treatment groups. Halitosis will be assessed using the organoleptic method and gas chromatography (OralChroma device) at three time points: before and after treatments. Microbiological samples will be collected before and after treatments from periodontal pockets and pooled samples from the tongue dorsum. These samples will be analyzed by using real-time PCR (q-PCR) aiming at detecting target bacterial species.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self-reported halitosis;
  • organoleptic score >2;
  • stage III periodontitis;
  • at least 14 teeth.

排除标准

  • smokers or former smokers;
  • individuals diagnosed with diabetes and/or immune diseases;
  • pregnant or lactating women;
  • individuals with removable partial dentures and/or fixed or removable orthodontic appliances;
  • systemic use of antibiotics or anti-inflammatory drugs in the last three months; - individuals who required prophylactic antibiotics for periodontal exams and treatments;
  • individuals who regularly used or had used any type of mouthwash in the past three months;
  • individuals who underwent periodontal treatment in the six months prior to the study.

结局指标

主要结局

sulfur volatile compounds changes

时间窗: baseline versus 21 and 45 days after treatment

pre and post-treatment changes in levels (parts per billion) of CH3SH, a sulfur volatile compound

次要结局

  • Changes in periodontal probing depth(baseline versus 45 days after treatment)
  • Changes in organoleptic testing(Baseline versus 45 days after treatment)
  • Changes in tongue total bacteria count(baseline versus 45 days after treatment)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando O Costa

titular professor

Federal University of Minas Gerais

研究点 (2)

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