A 4 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Health Functional Food Clinical Trial for the Evaluation of the Efficacy and Safety of BenTooth on Gingival Health
- Conditions
- Not Applicable
- Registration Number
- KCT0008485
- Lead Sponsor
- Ben’s Lab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
1) An adult male and female over 20 years of age and under 80 years of age
2) A person who has at least one tooth with a BLEEDING ON PROBING (BOP) site of 10% or more and a PD (Probing Depth) of 3 mm or more and 5 mm or less in all teeth
3) A person who has one or more teeth with a GI score of 2 or more
4) Those who have at least 20 natural teeth (excluding implants)
5) A person who agrees to participate in this human body application test before the start of the human body application test and prepares a written consent form
1) A person currently being treated for severe cardiovascular, immune, gastrointestinal/hepatic and biliary systems, kidney and urology, nervous, musculoskeletal, infectious diseases, etc
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 bleeding or disease, or is taking antiplatelet drugs or anticoagulants
5) A person who shows serious pathological findings in soft tissue in the oral cavity
6) A person who needs surgery, extraction, etc. treatment due to dental diseases accompanying the human body application test period
7) Women within 6 months of childbirth based on visit 1
8) A smoker
9) A person who has received scaling treatment within three months or periodontal treatment within six months of visiting
10) A person who has taken drugs (Phenytoin, CCBs, Cyclosporine, Coumadin, NSAIDs, Aspirin, etc.) that can affect periodontal conditions for at least 5 consecutive days within 1 month of visit 1
11) A person who has taken antibiotics or periodontal disease supplementary treatment within one month of visit 1
12) A person who has consumed health functional foods related to gum health within one month of visit 1
13) Patients with uncontrolled hypertension (measured by systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, test subjects after 10 minutes of stabilization)
14) Uncontrolled diabetics (e.g. fasting blood sugar >180 mg/dL or new medication initiated due to diabetes within 3 months)
15) Those whose creatine is more than twice the normal upper limit of the implementing agency
16) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the institution
17) A person who is pregnant, lactating, or plans to conceive during this human body application test
18) A person who has participated in another interventional clinical trial (including human application test) within three months of visit 1, or plans to participate in another interventional clinical trial (including human application test) after the start of this human application test
19) A person who is sensitive or allergic to food ingredients for this human body application test
20) A person who judges that the tester is inappropriate for other reasons
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), BOP(Bleeding On Probing);CAL(Clinical Attachment Level), PI(Plaque Index), GR(Gingival Recession), Biomarkers of Gingival Crevicular Fluid(IL-1ß, IL-6, MMP-9, MMP-13), OHIP-14((Oral Health Impact Profile-14)