Dental CariesPhase 2NCT07751016
A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
A Phase 2 study testing KH001 in people with Dental Caries, run by Seoul National University Dental Hospital at 1 site in South Korea.
Trial summary
The Purpose of this Study is to Evaluate Pulp Preservation and Safety of KH001 in the Administration of Deep Dentin Caries. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- KH001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2026to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Keumhee choi contact
South Korea1 site
Seoul National University Dental Hospital
Seoul
Sun-Young kim, +82-2-502-6700, denkim@snu.ac.kr
About this study
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
The Purpose of this Study is to Evaluate Pulp Preservation and Safety of KH001 in the Administration of Deep Dentin Caries.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- KH001, Placebo
- Keywords
- caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH001Drug
Topical applications of KH001
PlaceboDrug
Topical applications of saline
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | KH001 Receives: Drug: KH001 |
| Group B | Experimental | Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp preservation effect
Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis
Measured: Up to 24 weeks
Secondary outcomes (3)
Pulp preservation effect
Change in dentin thickness using periapical radiographs
Measured: Up to 4 weeks and 12 weeks
Incidence of Adverse Events(AEs) and Serious Adverse Events (SAEs)
number of participants experiencing any AEs and SAEs
Measured: Up to 24 weeks
Number of subjects with clinically significant abnormal safety findings
Assessed by changes from baseline in physical examinations, vital signs, and clinical laboratory tests
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Dental Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HysensBio Co., Ltd
- Responsible party
- Principal investigator, Sun-Young Kim, Seoul National University Dental Hospital
- Investigators
- Sun-Young Kim, Principal investigator, Seoul National University Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751016
- Sponsor's protocol ID
- KH-002-I202
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07751016
- Acronym / sponsor ID
- KH-002-I202
- Conditions
- Dental Caries
- Keywords
- caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Seoul National University Dental HospitalUniversity, hospital or other
- Collaborators
- HysensBio Co., Ltd
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: KH001KH001 |
| Group B | Experimental | Drug: PlaceboSaline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KH001Topical applications of KH001 | Drug | Group A |
| PlaceboTopical applications of saline | Drug | Group B |
Primary outcome
Pulp preservation effect
Time frame: Up to 24 weeks
Cumulative proportion of subjects developing symptoms of irreversible pulpitis or pulp necrosis
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keumhee choi contact
Sun-Young Kim principal investigator
Seoul National University Dental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KH001 in people with Dental Caries, run by Seoul National University Dental Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sun-Young Kim (+82-2-502-6700, denkim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp preservation effect (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.