Dentin CariesPhase 2NCT06580678
A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of Erupted Wisdom Tooth With Dentin Caries
A Phase 2 study testing KH001 in people with Dentin Caries, run by Byoung-Moo Seo at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 35 years
- Conditions the study is for
- Dentin Caries
- What is being tested?
- KH001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2024to 7 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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/application of investigational product/device
- Is judged by the investigator as ineligible for participation for other reasens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate Physiologic Dentin Regeneration When KH001 Was Administration to Erupted Wisdom Tooth With Dentin Caries
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
Read the 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.
- Conditions
- Dentin Caries
- Being tested
- KH001, Placebo
- Keywords
- Wisdom Tooth, Dentin Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH001Drug
topical application of KH001
PlaceboDrug
topical application of Water for Injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | KH001 Receives: Drug: KH001 |
| Group B | Placebo comparator | Water for Injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of physiological dentin formation
Histological analysis after wisdom tooth extraction by histological analysis
Measured: Week 5
Secondary outcomes (2)
Adverse Events
The adverse event name, onset date, resolution date, and other relevant details will be recorded until end of visit.
Measured: Up to 9 weeks
Oral soft/hard tissue examination
Evaluation of oral condition by referring to maximum probing depth.
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start6 Nov 2024
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin 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, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Byoung-Moo Seo
- Sponsor type
- University, hospital or other
- Collaborators
- HysensBio Co., Ltd
- Responsible party
- Sponsor-investigator, Byoung-Moo Seo, Seoul National University Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580678
- Sponsor's protocol ID
- KH-002-I201
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2024
- Last updated
- 13 Jan 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate Physiologic Dentin Regeneration When KH001 Was Administration to Erupted Wisdom Tooth With Dentin Caries
- ClinicalTrials.gov ID
- NCT06580678
- Acronym / sponsor ID
- KH-002-I201
- Conditions
- Dentin Caries
- Keywords
- Wisdom Tooth, Dentin Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Byoung-Moo SeoUniversity, hospital or other
- Collaborators
- HysensBio Co., Ltd
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 30 Aug 2024 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: KH001KH001 |
| Group B | Placebo comparator | Drug: PlaceboWater for Injection |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
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/application of investigational product/device
- Is judged by the investigator as ineligible for participation for other reasens
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 application of KH001 | Drug | Group A |
| Placebotopical application of Water for Injection | Drug | Group B |
Primary outcome
Evaluation of physiological dentin formation
Time frame: Week 5
Histological analysis after wisdom tooth extraction by histological analysis
2 secondary outcomes
Adverse Events
Time frame: Up to 9 weeks
Oral soft/hard tissue examination
Time frame: Up to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Dentin Caries, run by Byoung-Moo Seo 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: finished, as of the sponsor's last update on 13 Jan 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of physiological dentin formation (time frame: Week 5). 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 13 Jan 2026.