NCT06580678

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

August 11, 2024

Last Update Submit

January 11, 2026

Conditions

Dentin Caries

Keywords

Wisdom ToothDentin Caries

Outcome Measures

Primary Outcomes (1)

  • Evaluation of physiological dentin formation

    Histological analysis after wisdom tooth extraction by histological analysis

    Week 5

Secondary Outcomes (2)

  • Adverse Events

    Up to 9 weeks

  • Oral soft/hard tissue examination

    Up to 9 weeks

Study Arms (2)

Group A

EXPERIMENTAL

KH001

Drug: KH001

Group B

PLACEBO COMPARATOR

Water for Injection

Drug: Placebo

Interventions

KH001DRUG

topical application of KH001

Group A
PlaceboDRUG

topical application of Water for Injection

Group B

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Dental Hospital

Seoul, 03080, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 30, 2024

Study Start

November 6, 2024

Primary Completion

May 7, 2025

Study Completion

May 7, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)