Status:
NOT_YET_RECRUITING
A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of Erupted Wisdom Tooth With Dentin Caries
Lead Sponsor:
Byoung-Moo Seo
Collaborating Sponsors:
HysensBio Co., Ltd
Conditions:
Dentin Caries
Eligibility:
All Genders
19-35 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06580678
Start Date
September 13 2024
End Date
March 31 2025
Last Update
August 30 2024
Active Locations (1)
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1
Seoul National University Dental Hospital
Seoul, South Korea, 03080