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临床试验/KCT0005569
KCT0005569已完成未知

A 8 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of MAEC on gingival health

MedibioLAB0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
100

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.Men and women 20 years old or older and 75 years old or younger
  • 2. Those with more than 10% BOP (Bleeding on Probing) site and one or more teeth with PD (Probing Depth) greater than 3mm and less than 5mm
  • 3. Those with at least 18 existing natural teeth
  • 4. Those who signed the Informed Consent Form before the start of this clinical trial

排除标准

  • 1. Those who received scaling treatment and prophylactic periodontal treatment within 3 months of visit 1
  • 2. Persons with a history of bleeding or disease, or taking antiplatelet drugs or anticoagulants to prevent them
  • 3. Those with serious pathological findings on the soft tissues in the oral cavity (such as oral cancer patients)
  • 4. Those who have 5 or more teeth to be treated for dental caries immediately
  • 5. Patients with periodontitis requiring surgery or acute treatment
  • 7. Those who took antibiotics within 2 weeks of visit 1
  • 8. Patients with uncontrolled diabetes (fasting blood sugar greater than 180 mg/dl)
  • 9. Those whose AST(GOT) or ALT(GPT) is more than 3 times the upper limit of the laboratory
  • 10. Creatinine is more than twice the upper limit of the laboratory
  • 11. Those with clinically significant cardiovascular, immune system, infectious, and neoplastic diseases
  • 12. People with mental illness such as schizophrenia, depression, drug addiction, alcoholism, etc.
  • 13. Those who are allergic to the main ingredients of the test food
  • 14. Those who are pregnant or plan to become pregnant during this clinical trial, and those who are lactating
  • 15. Those who have participated in other clinical trials within 1 month of visit 1 or plan to participate during the clinical trial period
  • 16. A person who judges that the tester is inappropriate for this clinical trial

研究者

发起方
MedibioLAB

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