KCT0007862尚未招募未知
A Randomized, Double-blind, placebo-controlled, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Igatan F capsule in non-surgical therapy of Chronic periodontitis patients
Myungin Pharm0 个研究点目标入组 144 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Adults 19 years of age or older
- •2) Those with at least 16 residual teeth (excluding wisdom teeth and implants)
- •3) Those diagnosed with stage II or higher periodontitis*
- •? Radiographic bone loss of more than 15% of the root length
- •? The deepest periodontal pocket probe depth (PD) is 5 mm or more
- •? Interdental CAL at the most severe site is 3 mm or more
- •* 2) If the number of teeth satisfying the criteria ?, ?, ? compared to the number of residual teeth investigated in the standard is 30% or more, it is judged as stage II or higher general periodontitis.
- •4) A person who voluntarily signed a written informed consent after hearing the explanation of this clinical trial
排除标准
- •1) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •2) Patients with uncontrolled diabetes or hypertension (glycated hemoglobin > 8.0% or fasting blood glucose > 200 mg/dl, 160 mmHg = SBP or 100 mmHg = DBP within 3 months of screening)
- •3) Those who have taken antibiotics, steroids and NSAIDs for 3 days or more within 1 month of screening
- •4) Those with a history of malignancy within 5 years before screening
- •5) Those who are determined to be reactive as a result of antibody test (HIV, HCV)
- •6) Those who have undergone scaling or dental treatment within 1 month of screening
- •7) Those who have received periodontal treatment other than preventive dental treatment within 6 months of screening
- •8) Persons with orthodontic appliances or removable local dentures
- •9) Those with serious pathological findings in the soft tissues of the oral cavity, including oral cancer
- •10) Those who have 5 or more teeth that require immediate dental caries treatment in the oral cavity
- •11) Patients with a history of bleeding or disease, or taking antiplatelet or anticoagulant medications
- •12) hormonal drug users
- •13) Pregnant or lactating women or women of childbearing age who are unwilling to use appropriate contraceptive methods
- •14) Those who are taking medications for active peptic ulcer
- •15) Those who have a history of mental illness or are taking related medications
- •16) Smokers who smoke more than 10 cigarettes a day
- •17) Those who cannot quit smoking during this clinical trial period
- •18) Subjects who participated in other clinical trials within 6 months prior to screening
- •19) Those who are judged inappropriate to participate in this clinical trial according to the judgment of other researchers
研究者
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