KCT0007861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 peri-implantitis
Myungin Pharm0 个研究点目标入组 184 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
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) Implants with a functional load of at least 1 year
- •3) Those diagnosed with peri-implantitis based on the following criteria. If multiple implants satisfy the following criteria, the implant showing the most severe progression is selected.
- •? Probing depth =5mm
- •? BoP and/or pus
- •? Bone resorption around implant 2mm or more
- •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) Smokers who smoke more than 10 cigarettes a day
- •4) Those who have undergone scaling or periodontal treatment within 1 month of screening for selected implant teeth
- •5) Those who have taken antibiotics, steroids and NSAIDs for 3 days or more within 1 month of screening
- •6) Those with a history of malignancy within 5 years before screening
- •7) Those who are determined to be reactive as a result of antibody test (HIV, HCV)
- •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) Those who cannot quit smoking during this clinical trial period
- •17) Subjects who participated in other clinical trials within 6 months prior to screening
- •18) 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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