KCT0009501招募中未知
A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of DKB-140 on Gingival Health
Dong Kook Pharm0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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 80(Year)（—）
- 性别
- All
入选标准
- •1)An adult over 19 years of age and under 80 years of age
- •2)A person who has at least one tooth with a BLEEDING ON PROBING (BOP) site of 10% or more and a PD (Probing Depth) of 3 mm or more and 5 mm or less in all site(excluding those requiring medication or prescription for use of medication, and those with some sites falling into the 5 mm category due to attachment loss or moderate periodontitis)
- •3)A person who has one or more site with a GI score of 2 or more
- •4)Those who have at least 20 natural teeth (excluding implants and third molars)
- •5)A person who agrees to participate in this human body application test before the start of the human body application test and prepares a written consent form
排除标准
- •1)A person with clinically significant cardiovascular, immune, or 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 bleeding or disease
- •5)A person who shows serious pathological findings in soft tissue in the oral cavity{Desquamative gingivitis symptoms resulting from unknown causes, hormonal changes, immune system abnormalities, nonspecific oral reactions to systemic diseases(eg.Flat lesions and bullous lesions), or oral manifestations such as oral cancer, oral leukoplakia, palatal rugae, fibromas, and giant cell tumors of soft tissues}
- •6)A person with five or more teeth requiring immediate dental caries treatment within the oral cavity
- •7)A person requiring surgical or extraction procedures due to concurrent orthodontic or dental diseases during the trial period
- •8)A person who have received scaling treatment within 3 months of Visit 1 or periodontal treatment within 6 months of Visit 1
- •9)A person who have taken medications affecting periodontal status {including Phenytoin, CCBs, Cyclosporine, Anticoagulants (e.g., Coumadin), NSAIDs, Antiplatelets (e.g., Aspirin)} for more than 5 consecutive days within 1 month of Visit 1
- •10)A person who have taken antibiotics or adjunctive periodontal treatment within 1 month of Visit 1
- •11)A person who have consumed oral health-related functional foods within 1 month of Visit 1
- •12)A person who have consumed herbal medicine, health functional foods, or dietary supplements for anti-inflammatory or antioxidant purposes within 1 week of Visit 1
- •13)Patients with uncontrolled hypertension (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg, measured criteria after 10 minutes of rest for subjects undergoing human clinical trials)
- •14)Patients with uncontrolled diabetes (HbA1c > 7.0% or initiation of medication due to diabetes within 3 months of Visit 1, changes in dosage or medication currently being taken)
- •15)A person with Creatinine levels exceeding twice the upper limit of normal at the enrolling institution
- •16)A person with AST (GOT) or ALT (GPT) levels exceeding three times the upper limit of normal at the enrolling institution
- •17)Heavy smokers (=20 cigarettes/day)
- •18)Excessive alcohol consumers (men =40 g/day, women =20 g/day)
- •19)A person who have participated in another interventional clinical trial (including human clinical trials) within 3 months before Visit 1, or plan to participate in another interventional clinical trial (including human clinical trials) after the start of this human clinical trial
- •20)Pregnant or lactating women (including up to 6 months postpartum) or individuals planning pregnancy during the study period
- •21)A person sensitive or allergic to ingredients in the test food for this clinical trial
- •22)A person deemed inappropriate for participation by the investigator in this clinical trial
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