KCT0005569Completed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 sites100 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 75(Year) (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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