A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KH001, Placebo.
- Who it may be relevant to
- Registry conditions: Dental Caries. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Single-center, Double-blinded, Placebo-controlled, Investigator-initiated Trial to Evaluate the Efficacy and Safety of KH001 in Patients With Deep Dentinal Caries
Overview
The Purpose of this Study is to Evaluate Pulp Preservation and Safety of KH001 in the Administration of Deep Dentin Caries.
Detailed description
The Design is a Single Site, Double-Blind, Randomized Study. Subjects will be Randomly Assigned to Either the KH001 or Placebo (normal saline) group, and Administered the Investigational Product for Efficacy and Safety. The Total Duration of the Study will be Approximately 24 Weeks.
Interventions
- Drug KH001
Topical applications of KH001 - Drug Placebo
Topical applications of saline
Primary outcome measures
- Pulp preservation effect [Time frame: Up to 24 weeks]
Secondary outcome measures (3)
- Pulp preservation effect [Time frame: Up to 4 weeks and 12 weeks]
- Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 24 weeks]
- Number of subjects with clinically significant abnormal safety findings [Time frame: Up to 24 weeks]
Eligibility criteria
Inclusion criteria
- Is ≥ 19 years old by the time of the screening visit.
- Has signed written informed consent in the study.
- Subjects who can comply with oral hygiene during the study period.
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 of investigational product.
- Is judged by the investigator as ineligible for participation for other reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
South Korea · 1 center
- Seoul National University Dental Hospital — Seoul
Identifiers
NCT: NCT07751016 · KH-002-I202