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

NCT ID: NCT06580678

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Dentin Caries

Keywords

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Wisdom Tooth Dentin Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

KH001

Group Type EXPERIMENTAL

KH001

Intervention Type DRUG

topical application of KH001

Group B

Water for Injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

topical application of Water for Injection

Interventions

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KH001

topical application of KH001

Intervention Type DRUG

Placebo

topical application of Water for Injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HysensBio Co., Ltd

INDUSTRY

Sponsor Role collaborator

Byoung-Moo Seo

OTHER

Sponsor Role lead

Responsible Party

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Byoung-Moo Seo

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Seoul National University Dental Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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KeumHee choi

Role: CONTACT

Phone: +82-2-502-6700

Email: [email protected]

Byoung-Moo Seo

Role: CONTACT

Phone: +82+2-2072-3369

Email: [email protected]

Facility Contacts

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Byoung-Moo Seo

Role: primary

Other Identifiers

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KH-002-I201

Identifier Type: -

Identifier Source: org_study_id