KCT0006746招募中未知
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
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- O
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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