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
- Conditions
- Congenital malformations, deformations and chromosomal abnormalities
- Registration Number
- KCT0005569
- Lead Sponsor
- MedibioLAB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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
6. smoker
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GI(Gingival Index)
- Secondary Outcome Measures
Name Time Method PD(Probing Depth);CAL(Clinical Attachment Level);PI(Plaque Index);BOP(Bleeding on probing);GR(Gingival Recession);Biomarkers of saliva and gingival fissures(IL-1ß, IL-6, MMP-8, MMP-9);Oral Health Impact Profile-14(OHIP-14)