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: 2020年12月2日

研究概览

暂无简介。

•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

•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

发起方

MedibioLAB