NCT07751016尚未招募2 期
A Randomized, Single-center, Double-blinded, Placebo-controlled, Investigator-initiated Trial to Evaluate the Efficacy and Safety of KH001 in Patients With Deep Dentinal Caries
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pulp preservation effect
研究概览
简要总结
The Purpose of this Study is to Evaluate Pulp Preservation and Safety of KH001 in the Administration of Deep Dentin Caries.
详细描述
The Design is a Single Site, Double-Blind, Randomized Study. Subjects will be Randomly Assigned to Either the KH001 or Placebo (normal saline) group, and Administered the Investigational Product for Efficacy and Safety. The Total Duration of the Study will be Approximately 24 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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is ≥ 19 years old by the time of the screening visit.
- •Has signed written informed consent in the study.
- •Subjects who can comply with oral hygiene during the study period.
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 of investigational product.
- •Is judged by the investigator as ineligible for participation for other reasons.
研究组 & 干预措施
Group B
Experimental
Saline
干预措施: Placebo (Drug)
Group A
Experimental
KH001
干预措施: KH001 (Drug)
结局指标
主要结局
Pulp preservation effect
时间窗: Up to 24 weeks
Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis
次要结局
- Pulp preservation effect(Up to 4 weeks and 12 weeks)
- Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)(Up to 24 weeks)
- Number of subjects with clinically significant abnormal safety findings(Up to 24 weeks)
研究者
Sun-Young Kim
Sun-Young Kim
Seoul National University Dental Hospital
研究点 (1)
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