None listed
Conditions
Interventions
Others(health functional food) : Test group: KGC19b (ginseng fruit extract)
Control group: placebo of KGC19b (ginseng fruit extract)
Ingestion Method: The test subjects are randomly assigned to one gr
Sponsors
Korea Ginseng Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female between the ages of 19 and less than 80 and have symptoms of gingivitis or mild periodontitis 2) Those with a BLEEDING ON PROBING (BOP) site of 10% or more of teeth 3) A person who has at least one tooth with a depth of more than 3 mm and less than 5 mm 4) A person who has at least one tooth with a gingival index of 2 or more 5) Those with 18 or more teeth remaining (excluding implants) 6) A person who agrees not to perform periodontal treatment during this human body application test 7) A person who voluntarily agrees to participate in this human body application test and is capable of understanding and complying with the progress
Exclusion criteria
Exclusion criteria: 1) a person with a history of hemorrhagic disease or disease 2) A person who has taken drugs that may affect his/her periodontal condition for at least five consecutive days within the last one month 3) A person who has received periodontal treatment within the last 6 months 4) A person who has serious pathological findings on soft tissue in the oral cavity 5) a periodontal inflammatory patient requiring surgery or acute treatment 6) Patients who have developed cancer within the past five years 7) If periodontal surgery, etc. is required during the examination period 8) an uncontrolled hypertensive patient 9) Patients with uncontrolled diabetes (HbA1C > 7.0%) 10) Persons with clinically significant cardiovascular, immune, infectious, and neoplastic diseases 11) Mental illness such as schizophrenia, drug addiction, alcoholism, etc 12) Vegetarian who restricts the consumption of dairy products and eggs 13) Pregnant women and lactating women or persons with pregnancy plans 14) Those who have allergies/side effects on ingredients contained in test and control foods ? Test Food: Ginseng fruit extract ? Contrast Foods: Crystal Cellulose 15) Excessive drinkers (men = 40 g/day, women = 20 g/day) 16) Excessive smokers (=20 cigarettes/day) 17) A person who has taken gum health-related drugs (including supplementary treatments) or health functional foods within one month of the start of the test 18) A person who has participated in another human body application test or has a plan to participate within the last one month 19) A person who shows the following results in the results of a diagnostic test medical examination - AST, ALT > 3x the upper limit of normal - eGFR < 60 mL/min/1.73 m2 character 20) A person who finds that the person in charge of testing is not suitable for participation in the study due to the results of diagnostic test and medical examination and other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic test medical results;Gingival Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Probing Depth;Plaque Index;Bleeding on Probing;Anti-inflammatory biomarkers (IL-1ß, IL-6);periodontal tissue and structural changes biomarkers (MMP-1, MMP-8, MMP-9, ALP);antioxidant enzyme activity (SOD; Superoxide Dismutase);7 types of harmful bacteria in the mouth | — |
Countries
Korea, Republic of
Contacts
Public ContactEUNHUI CHOI
Hallym University Medical Center
Outcome results
None listed