NCT06580678已完成2 期
A Clinical Study to Evaluate Physiologic Dentin Regeneration When KH001 Was Administration to Erupted Wisdom Tooth With Dentin Caries
Byoung-Moo Seo1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年11月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluation of physiological dentin formation
研究概览
简要总结
The purpose of this study is to evaluate physiologic dentin regeneration and safety of KH001 in the administration of erupted wisdom tooth with dentin caries
详细描述
The design is a single site, double-blind, randomized study. Phase 2 study to evaluate physiologic dentin regeneration and safety of KH001. The total duration of the study will be approximately 5 to 9 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between 19 and 35 of age by the time of the screening
- •Has signed written informed consent in the study
- •Subject who either have no pain in the affected tooth, or can endure pain until the day of tooth extraction
排除标准
- •Is allergic to the active ingredient or other ingredients used in the investigational product
- •Have participated in another clinical study within 30 days from screening visit and have a history of administration/application of investigational product/device
- •Is judged by the investigator as ineligible for participation for other reasens
研究组 & 干预措施
Group A
Experimental
KH001
干预措施: KH001 (Drug)
Group B
Placebo Comparator
Water for Injection
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of physiological dentin formation
时间窗: Week 5
Histological analysis after wisdom tooth extraction by histological analysis
次要结局
- Adverse Events(Up to 9 weeks)
- Oral soft/hard tissue examination(Up to 9 weeks)
研究者
Byoung-Moo Seo
Principal Investigator
Seoul National University Dental Hospital
研究点 (1)
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