KCT0008940已完成Unknown
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 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 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
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
- •11) A person who has taken antibiotics and periodontal disease adjuvant therapy within one month based on visit 1
- •12) A person who has consumed health functional foods related to gum health within one month as of visit 1
- •13) Patients with uncontrolled hypertension (measurement criteria after stabilizing for 10 minutes or more of systolic blood pressure of 160 mmHg or diastolic blood pressure of 100 mmHg or more, and test subjects)
- •14) Uncontrolled Diabetes Patients (HbA1c 6.5% or more or if they start a new drug due to diabetes within 3 months)
- •15) A person 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 implementation agency
- •17) A person who is pregnant or has a plan to become pregnant during this human body application test
- •18) A person who has participated in another interventional clinical trial (including human application trial) within one month of visit 1, or plans to participate in another interventional clinical trial (including human application trial) after the start of this human application trial
- •19) A person who is sensitive or allergic to food ingredients for this human study
- •20) A person who judges that the tester is inappropriate for other reasons
研究者
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