NCT07751016Not yet recruitingPhase 2
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
Seoul National University Dental Hospital1 site in 1 country36 target enrollmentStarted: September 30, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Pulp preservation effect
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group B
Experimental
Saline
Intervention: Placebo (Drug)
Group A
Experimental
KH001
Intervention: KH001 (Drug)
Outcomes
Primary Outcomes
Pulp preservation effect
Time Frame: Up to 24 weeks
Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis
Secondary Outcomes
- Pulp preservation effect(Up to 4 weeks and 12 weeks)
- Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)(Up to 24 weeks)
- Number of subjects with clinically significant abnormal safety findings(Up to 24 weeks)
Investigators
Sun-Young Kim
Sun-Young Kim
Seoul National University Dental Hospital
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 3 4
Comparing the effectiveness of different materials to protect and heal the tooths inner tissue (the pulp) when its exposed during treatment of deep cavitiesCTRI/2025/02/080563Agarwal Namrata40
Not yet recruiting
Not Applicable
Evaluation of Indirect Pulp Capping Using Two Bioactive Materials.CTRI/2025/06/089893Dr Angha Uday Patil50
Not yet recruiting
Phase 2
Comparing the success of three dental materials i.e calcium hydroxide, calcium silicate, and resin-modified calcium silicate used to protect tooth decay in back teeth: a clinical study.CTRI/2026/02/103996J.N Kapoor Dav Dental College Yamunanagar110
Recruiting
Phase 3
Comparison of 3 different Rotary File Systems with hand files.CTRI/2024/11/076924Department of Pedodontics200
Not yet recruiting
Phase 2
Comparision of three materials used after pulp therapyCTRI/2024/06/068984Mohil Kale45