Dentin HypersensitivityPhase 2NCT06264453
A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity
A Phase 2 study testing KH001 in people with Dentin Hypersensitivity, run by HysensBio Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dentin Hypersensitivity
- 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
- 171 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Mar 2024to 25 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 19 years old by the time of the screening visit
- Be in good general health as determined by the investigator
- Have at least 2 non-adjacent teeth and is diagnosed with hypersensitive
Who cannot join
- Is allergic to the active drug substance or other excipients used in the investigational product
- Has any history of alcohol or drug abuse
- Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
- Has active dental caries or history of dental caries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-designed, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity
The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.
Read the detailed description
This study is multicenter, double-blind, placebo-controlled, randomized, parallel-designed, phase 2 study to evaluate the efficacy and safety of KH001. The total duration of the study will be approximately 7 to 11 weeks. Clinical safety evaluations will include physical examinations, vital signs, clinical laboratory results, and Adverse Event monitoring.
- Conditions
- Dentin Hypersensitivity
- Being tested
- KH001, Placebo
- Keywords
- Dentin Sensitivity, Denin Hypersensitivity
- Medical subject headings
- Dentin Sensitivity
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 Water for Injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | KH001 0.2mg/mL Receives: Drug: KH001 |
| Group B | Experimental | KH001 0.4mg/mL Receives: Drug: KH001 |
| Group C | 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.
Change from baseline in Schiff sensitivity score
Schiff sensitivity score 0-3 by air blast
Measured: Baseline and Day 36
Secondary outcomes (3)
Change from baseline in a Schiff sensitivity score
Schiff sensitivity score 0-3 by an evaporative air
Measured: Baseline, Day 8, 15, 22 and 43
Change from baseline in a Tactile threshold
Tactile threshold by yeaple probe
Measured: Baseline, Day 8, 15, 22, 36 and 43
Change from baseline in Visual Analogue Scale
100mm Visual Analogue Scale
Measured: Baseline, Day 8, 15, 22, 36 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start19 Mar 2024
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- HysensBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoung-Kyu Choi, D.D.S, Principal investigator, Kyung Hee University Dentistry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264453
- Sponsor's protocol ID
- KH-001-D201
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2024
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-designed, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT06264453
- Acronym / sponsor ID
- KH-001-D201
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin Sensitivity, Denin Hypersensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- HysensBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 20 Feb 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 the efficacy and safety of KH001 in patients with dentin hypersensitivity.
Detailed description
This study is multicenter, double-blind, placebo-controlled, randomized, parallel-designed, phase 2 study to evaluate the efficacy and safety of KH001. The total duration of the study will be approximately 7 to 11 weeks. Clinical safety evaluations will include physical examinations, vital signs, clinical laboratory results, and Adverse Event monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: KH001KH001 0.2mg/mL |
| Group B | Experimental | Drug: KH001KH001 0.4mg/mL |
| Group C | Placebo comparator | Drug: PlaceboWater for Injection |
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 at least 19 years old by the time of the screening visit
- Be in good general health as determined by the investigator
- Have at least 2 non-adjacent teeth and is diagnosed with hypersensitive
Key exclusion criteria (4 listed)
- Is allergic to the active drug substance or other excipients used in the investigational product
- Has any history of alcohol or drug abuse
- Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
- Has active dental caries or history of dental caries
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, Group B |
| Placebotopical applications of Water for Injection | Drug | Group C |
Primary outcome
Change from baseline in Schiff sensitivity score
Time frame: Baseline and Day 36
Schiff sensitivity score 0-3 by air blast
3 secondary outcomes
Change from baseline in a Schiff sensitivity score
Time frame: Baseline, Day 8, 15, 22 and 43
Change from baseline in a Tactile threshold
Time frame: Baseline, Day 8, 15, 22, 36 and 43
Change from baseline in Visual Analogue Scale
Time frame: Baseline, Day 8, 15, 22, 36 and 43
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 14 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Dentin Hypersensitivity
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
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.
Kyoung-Kyu Choi, D.D.S principal investigator
Kyung Hee University Dentistry 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 Dentin Hypersensitivity, run by HysensBio Co., Ltd 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 4 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 14 Mar 2025. 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?
Change from baseline in Schiff sensitivity score (time frame: Baseline and Day 36). 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 14 Mar 2025.