The Purpose of this Study is to Evaluate Pulp Preservation and Safety of KH001 in the Administration of Deep Dentin Caries.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
36
Seoul National University Dental Hospital
Seoul, South Korea
Pulp preservation effect
Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis
Time frame: Up to 24 weeks
Pulp preservation effect
Change in dentin thickness using periapical radiographs
Time frame: Up to 4 weeks and 12 weeks
Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)
number of participants experiencing any AEs and SAEs
Time frame: Up to 24 weeks
Number of subjects with clinically significant abnormal safety findings
Assessed by changes from baseline in physical examinations, vital signs, and clinical laboratory tests
Time frame: Up to 24 weeks
Keumhee choi
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