NCT07751016

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
21mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

July 22, 2026

Last Update Submit

August 3, 2026

Conditions

Dental Caries

Keywords

caries

Outcome Measures

Primary Outcomes (1)

  • Pulp preservation effect

    Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis

    Up to 24 weeks

Secondary Outcomes (3)

  • Pulp preservation effect

    Up to 4 weeks and 12 weeks

  • Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)

    Up to 24 weeks

  • Number of subjects with clinically significant abnormal safety findings

    Up to 24 weeks

Study Arms (2)

Group A

EXPERIMENTAL

KH001

Drug: KH001

Group B

EXPERIMENTAL

Saline

Drug: Placebo

Interventions

KH001DRUG

Topical applications of KH001

Group A
PlaceboDRUG

Topical applications of saline

Group B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Dental Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Sun-Young Kim

    Seoul National University Dental Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun-Young Kim

CONTACT

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

Keumhee choi

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sun-Young Kim

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 6, 2026

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)