A Study to Evaluate Physiologic Dentin Regeneration and S... | NCT06580678

Studies
A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of Erupted Wisdom Tooth With Dentin Caries

NCT06580678

Sponsor

Byoung-Moo Seo

Status

Completed

Last Update Posted

Jan 13, 2026Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Dentin Caries

Interventions

KH001
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2024Actual

Primary Completion Date

May 7, 2025Actual

Completion Date

May 7, 2025Actual

First Submitted Date

Aug 11, 2024

First Submission Date that Met QC Criteria

Aug 29, 2024

First Posted Date

Aug 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2026

Last Update Posted Date

Jan 13, 2026Actual

Name	Class
HysensBio Co., Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate physiologic dentin regeneration and safety of KH001 in the administration of erupted wisdom tooth with dentin caries

Detailed Description

The design is a single site, double-blind, randomized study. Phase 2 study to evaluate physiologic dentin regeneration and safety of KH001. The total duration of the study will be approximately 5 to 9 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	KH001	Drug: KH001
Group B	Placebo Comparator	Water for Injection	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KH001	Drug	topical application of KH001	Group A
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of physiological dentin formation	Histological analysis after wisdom tooth extraction by histological analysis	Week 5

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	The adverse event name, onset date, resolution date, and other relevant details will be recorded until end of visit.	Up to 9 weeks
Oral soft/hard tissue examination	Evaluation of oral condition by referring to maximum probing depth.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is between 19 and 35 of age by the time of the screening
Has signed written informed consent in the study
Subject who either have no pain in the affected tooth, or can endure pain until the day of tooth extraction

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/application of investigational product/device
Is judged by the investigator as ineligible for participation for other reasens

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Dental Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided