KCT0008940
Completed
未知
A 8 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Human Study for the Evaluation of the Efficacy and Safety of PMEC on Gingival health
MedibioLAB0 sites100 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MedibioLAB
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adult men and women over the age of 20 and under the age of 70
- •2\) BOP (Bleeding on Proving) site 10% of all teeth
- •3\) A person with at least one tooth with a Proving Depth (PD) of 3 mm or more, 5 mm or less, and a GI of at least 2 points
- •4\) Those with at least 20 existing natural teeth (excluding implants)
- •5\) A person who agrees to participate in this human study and prepares an Informed Consent Form before the start of the Human Study
Exclusion Criteria
- •1\) Those with clinically significant cardiovascular, immune and infectious diseases
- •2\) mentally ill patients such as schizophrenia, depression, and drug addiction
- •3\) a person who has developed cancer within the past five years
- •4\) A person who has a history of hemorrhagic disease or is taking antiplatelet drugs or anticoagulants to prevent them
- •5\) A person with severe pathological findings on soft tissue in the oral cavity
- •6\) A person who needs treatment for surgery, extraction, etc. due to a dental disease accompanying him/her during the human body application test
- •7\) Women within 6 months of childbirth based on visit 1
- •8\) a smoker
- •9\) A person who has received scaling treatment or periodontal treatment within 6 months based on visit 1
- •10\) Drugs that can affect periodontal status within one month based on visit 1 (Ph)A person who has taken enytoin, CCBs, Cyclosporine, Coumadin, NSAIDs, Aspirin, etc.) for more than 5 consecutive days
Outcomes
Primary Outcomes
Not specified
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