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

Byoung-Moo Seo

Status and phase: Not yet enrolling; Phase 2

Conditions: Dentin Caries

Treatments: Drug: Placebo; Drug: KH001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06580678

KH-002-I201

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 19 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

KH001

Treatment:

Drug: KH001

Group B

Placebo Comparator group

Description:

Water for Injection

Treatment:

Drug: Placebo