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

A Clinical Study to Evaluate Physiologic Dentin Regeneration When KH001 Was Administration to Erupted Wisdom Tooth With Dentin Caries

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

Study Overview

• Status: Completed
• Conditions: Dentin Caries
• Intervention / Treatment: Drug: KH001; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; KH001	Drug: KH001; topical application of KH001
Placebo Comparator: Group B; Water for Injection	Drug: Placebo; topical application of Water for Injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	Up to 9 weeks

Collaborators and Investigators

• Sponsor: Byoung-Moo Seo
• Collaborators: HysensBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Actual): May 7, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Wisdom Tooth; Dentin Caries
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: KH-002-I201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No