NCT06580678
Completed
Phase 2
A Clinical Study to Evaluate Physiologic Dentin Regeneration When KH001 Was Administration to Erupted Wisdom Tooth With Dentin Caries
Byoung-Moo Seo1 site in 1 country12 target enrollmentNovember 6, 2024
Overview
- Phase
- Phase 2
- Intervention
- KH001
- Conditions
- Dentin Caries
- Sponsor
- Byoung-Moo Seo
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Evaluation of physiological dentin formation
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Byoung-Moo Seo
Principal Investigator
Seoul National University Dental Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Group A
KH001
Intervention: KH001
Group B
Water for Injection
Intervention: Placebo
Outcomes
Primary Outcomes
Evaluation of physiological dentin formation
Time Frame: Week 5
Histological analysis after wisdom tooth extraction by histological analysis
Secondary Outcomes
- Adverse Events(Up to 9 weeks)
- Oral soft/hard tissue examination(Up to 9 weeks)
Study Sites (1)
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