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临床试验/KCT0005397
KCT0005397招募中未知

A 8 week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical trial for the Evaluation of the Efficacy and Safety of DSE01 on Gingival Health

Duksung Women's University0 个研究点目标入组 50 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 75(Year)(—)
性别
All

入选标准

  • 1) Adult male and female under 20 years old and under 75
  • years old 2) Those who have 10% or more of BOP (Bleeding on probing) site in
  • all teeth and 1 or more teeth with PD (Probing Depth) of more than 3mm and 5mm
  • or less 3) Those who have at least 18 existing natural teeth (excluding
  • implants) 4) A person who has signed the Informed Consent Form before the test

排除标准

  • 1) Those who received scaling treatment and preventive
  • periodontal treatment within 3 months of Visit 1 2) People with a history of
  • hemorrhagic disease or disease, or those taking antiplatelet or anticoagulant
  • drugs to prevent them 3) Those with severe pathological findings in the soft
  • tissues of the oral cavity (oral cancer patients) 4) Those who have 5 or more
  • target teeth to be treated immediately for dental caries 5) Periodontitis
  • patients requiring surgery or acute treatment 6) Smokers who smoke more than 10
  • cigarettes a day 7) Those who took antibiotics within 2 weeks of Visit 1 8)
  • Diabetes patients whose blood sugar is not controlled (over 180mg/dl of blood
  • sugar when fasting) 9) Those whose AST(GOT) or ALT(GPT) is 3 times or more than
  • the normal upper limit of the test institution 10) Those whose Creatinine is
  • more than twice the normal upper limit of the test institution 11) Patients with
  • clinically significant cardiovascular, immune system, infectious and oncological
  • diseases 12) People with mental illness such as schizophrenia, depression, drug
  • addiction, alcoholism 13) Those who are allergic to the main ingredients of the
  • food for testing 14) Those who are pregnant or who are planning to become
  • pregnant or lactating during this human trial 15) Persons who participated in
  • other interventional clinical trials (including human trials) within one month
  • of Visit 1 or plan to participate in other interventional trials (including
  • human trials) after the start of this human trial. 16) A person who is
  • inappropriate for this human application test by the
  • investigator

研究者

发起方
Duksung Women's University

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