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

Phase 2

Not yet recruiting

• Conditions: Dentin Caries
• Interventions: Drug: KH001; Drug: Placebo

• Registration Number: NCT06580678
• Lead Sponsor: Byoung-Moo Seo

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

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-29
• Last Update Submitted: 2024-08-29
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Study Start: 2024-09-13
• Primary Completion: 2025-03-24
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	KH001	KH001
Group B	Placebo	Water for Injection

Primary Outcome Measures

Name	Time	Method
Evaluation of physiological dentin formation	Week 5	Histological analysis after wisdom tooth extraction by histological analysis

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to 9 weeks	The adverse event name, onset date, resolution date, and other relevant details will be recorded until end of visit.
Oral soft/hard tissue examination	Up to 9 weeks	Evaluation of oral condition by referring to maximum probing depth.

Trial Locations

Locations (1)

Seoul National University Dental Hospital; 🇰🇷 Seoul, Korea, Republic of