A 8 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Magnolia extract on gingival health
- Conditions
- Not Applicable
- Registration Number
- KCT0006746
- Lead Sponsor
- O
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Adult male and female under 20 years old and under 80 years old
2) Those who have 10% or more of BOP (Bleeding on probing) site in all teeth and 1 or more teeth with PD (Probing Depth) of more than 3mm and 5mm or less
3) Those who have one or more teeth with a GI of 2 or more
4) Those who have at least 20 existing natural teeth (excluding implants)
5) Those who have consented to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
1) Those with clinically significant cardiovascular, immune system, infectious diseases
2) People with mental illness such as schizophrenia, depression, drug addiction, etc.
3) Patients who have developed cancer within the last 5 years
4) Persons with a history of bleeding or disease, or taking antiplatelet drugs or anticoagulants to prevent them
5) Those with serious pathological findings on the soft tissues in the oral cavity
6) Those who need treatment such as surgery or extraction due to dental diseases that accompany them during the test period.
7) Patients with uncontrolled hypertension (fasting blood sugar greater than 180 mg/dl)
8) Patients with uncontrolled diabetes (fasting blood sugar greater than 180 mg/dl) sfsdfsdfsdfsdfsdfsdf
9) Those whose Creatinine is more than twice the upper limit of the laboratory
10) Those whose AST(GOT) or ALT(GPT) is more than 3 times the upper limit of the laboratory
11) Those who drink excessive alcohol
12) smoker
13) Those who received scaling treatment within 3 months, or periodontal treatment within 6 months of visit 1
14) Those who have taken drugs that can affect periodontal conditions(Phenytoin, CCBs, Cyclosporine, Coumadin, NSAIDs, Aspirin etc) for 5 or more consecutive days within 1 month based on visit 1
15) Those who took antibiotics or periodontal disease supplementary treatment within 1 month based on visit 1
16) Those who have consumed health functional foods related to gum health within 1 month based on visit 1
17) Those who have participated in other interventional clinical trials (including human trials) within 1 month of Visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
18) Those who are pregnant, lactating, or planning to become pregnant during this human application test period
19) Women within 6 months of childbirth based of visit 1
20) Those who are sensitive to or allergic to the food ingredients for this human trial
21) A person who judges that the tester is inappropriate for this human trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gingival Index
- Secondary Outcome Measures
Name Time Method Probing Depth;Bleeding On Probing;Gingival Recession;Clinical Attachment Level;Plaque Index;Biomarkers of gingival fissures(IL-1ß, IL-6, MMP-8, MMP-9);Oral Health Impact Profile-14