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NCT Number: NCT07751016

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

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KH001

Drug

Topical applications of KH001

Placebo

Drug

Topical applications of saline

Primary outcomes

  1. Pulp preservation effect

    Time frame: Up to 24 weeks

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

Secondary outcomes

  1. Pulp preservation effect

    Time frame: Up to 4 weeks and 12 weeks

    Change in dentin thickness using periapical radiographs

  2. Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 24 weeks

    number of participants experiencing any AEs and SAEs

  3. Number of subjects with clinically significant abnormal safety findings

    Time frame: Up to 24 weeks

    Assessed by changes from baseline in physical examinations, vital signs, and clinical laboratory tests

Study contacts

Contact information is provided by the study sponsor or research team.

Keumhee choi

CONTACT

Sun-Young Kim

CONTACT

[email protected]

+82-2-502-6700

Sponsors and collaborators

Lead sponsor

Seoul National University Dental Hospital

Other

Collaborators

  • HysensBio Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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