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Completed

NCT Number: NCT06580678

A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of 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

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Key information

Conditions

Dentin Caries

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Dental Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

KH001

Drug

topical application of KH001

Placebo

Drug

topical application of Water for Injection

Primary outcomes

  1. Evaluation of physiological dentin formation

    Time frame: Week 5

    Histological analysis after wisdom tooth extraction by histological analysis

Secondary outcomes

  1. Adverse Events

    Time frame: Up to 9 weeks

    The adverse event name, onset date, resolution date, and other relevant details will be recorded until end of visit.

  2. Oral soft/hard tissue examination

    Time frame: Up to 9 weeks

    Evaluation of oral condition by referring to maximum probing depth.

Sponsors and collaborators

Lead sponsor

Byoung-Moo Seo

Other

Collaborators

  • HysensBio Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Jan 13, 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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