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临床试验/NCT06327841
NCT06327841已完成不适用

The Plaque Reducing Efficacy of Oil Pulling With Sesame Oil. A Randomized-controlled Clinical Study

Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年6月21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
Rustogi Modified Navy Plaque Index (RMNPI)

研究概览

简要总结

The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:

• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.

Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect.

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
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 18 years
  • contractual capability
  • the presence of ≥ 10 teeth,
  • community periodontal index of treatment needs (CPITN) grade 1 or 2

排除标准

  • missing consent
  • community periodontal index of treatment needs (CPITN) grade 0, 3 or 4
  • pregnancy or breastfeeding
  • systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment
  • mental and behavioral disorders that impede (verbal) communication
  • allergy against sesame(oil)
  • intake of antibiotics 6 months prior to or during study duration
  • intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone)
  • infectious diseases (e.g. HIV, hepatitis B or C)
  • fixed orthodontic appliances
  • ongoing oil pulling or mouth rinsing
  • adult guardianship
  • insufficient nasal breathing

结局指标

主要结局

Rustogi Modified Navy Plaque Index (RMNPI)

时间窗: first follow up after 4 weeks, full study duration 8 weeks

次要结局

  • Gingival Index (GI)(first follow up after 4 weeks, full study duration 8 weeks)
  • Oral Health Impact Profile (OHIP)(first follow up after 4 weeks, full study duration 8 weeks)
  • microbial analysis(first follow up after 4 weeks, full study duration 8 weeks)
  • Interview halitosis, xerostomia(first follow up after 4 weeks, full study duration 8 weeks)

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Zürcher

Dr.med.dent.

Medical University Innsbruck

研究点 (2)

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