A Phase 2 interventional study of KH001 and Placebo in Dental Caries, sponsored by Seoul National University Dental Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Seoul National University Dental Hospital · Phase 2, Interventional, and Supportive care
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.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Seoul National University Dental Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KH001
Drug: KH001
Saline
Drug: Placebo
Topical applications of KH001
Topical applications of saline
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: KH001
Seoul National University Dental Hospital