A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries

A Randomized, Single-center, Double-blinded, Placebo-controlled, Investigator-initiated Trial to Evaluate the Efficacy and Safety of KH001 in Patients With Deep Dentinal Caries

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07751016

Enrollment

Registered

2026-08-06

Start date

2026-09-30

Completion date

2028-06-30

Last updated

2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

caries

Brief summary

The Purpose of this Study is to Evaluate Pulp Preservation and Safety of KH001 in the Administration of Deep Dentin Caries.

Detailed description

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.

Interventions

DRUGKH001

Topical applications of KH001

DRUGPlacebo

Topical applications of saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

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 of investigational product. * Is judged by the investigator as ineligible for participation for other reasons.

Design outcomes

Primary

Measure	Time frame	Description
Pulp preservation effect	Up to 24 weeks	Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis

Secondary

Measure	Time frame	Description
Pulp preservation effect	Up to 4 weeks and 12 weeks	Change in dentin thickness using periapical radiographs
Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)	Up to 24 weeks	number of participants experiencing any AEs and SAEs
Number of subjects with clinically significant abnormal safety findings	Up to 24 weeks	Assessed by changes from baseline in physical examinations, vital signs, and clinical laboratory tests

Countries

South Korea

Contacts

CONTACTSun-Young Kim

denkim@snu.ac.kr+82-2-502-6700

CONTACTKeumhee choi

PRINCIPAL_INVESTIGATORSun-Young Kim

Seoul National University Dental Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026