The Purpose of this Study is to Evaluate Pulp Preservation and Safety of KH001 in the Administration of Deep Dentin Caries.
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.
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.
Parallel
KH001
DrugTopical applications of KH001
Placebo
DrugTopical applications of saline
Pulp preservation effect
Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis
Pulp preservation effect
Change in dentin thickness using periapical radiographs
Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)
number of participants experiencing any AEs and SAEs
Number of subjects with clinically significant abnormal safety findings
Assessed by changes from baseline in physical examinations, vital signs, and clinical laboratory tests
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Seoul National University Dental Hospital
Lead sponsor
HysensBio Co., Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
