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 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Diseases of the digestive system
- 发起方
- Myungin Pharm
- 入组人数
- 184
- 状态
- 尚未招募
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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