Dentin HypersensitivityPhase 2NCT06464939
Phase 2 Study of KH001 in Long-term Relief From Dentin Hypersensitivity
A Phase 2 study testing KH001 in people with Dentin Hypersensitivity, run by HysensBio Co., Ltd at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 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
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2024to 22 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years old by the time of the screening visit
- Is in good general health as determined by the investigator
- Has 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
- Is jedged by the investigator as ineligible for participation for other reasons
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ADA Forsyth
Cambridge, Massachusetts, 02142
Forsyth Institute
Cambridge, Massachusetts, 02142
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of Three Topical Applications of KH001 in Providing Long-term Relief From Dentin Hypersensitivity
The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.
Read the detailed description
The study will consist of a screening period, a treatment period, and a follow-up period. The total duration of the study for each subject will be approximately 8 to 12 weeks. All subjects will be randomly assigned in a 1:1:1 ratio, with Group A, Group B and Group C.
- 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
Application of KH001 over a 1 or 2-week period
PlaceboDrug
Applications of water for injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | KH001 and placebo Receives: Drug: KH001; Drug: Placebo |
| Group B | Experimental | KH001 and placebo Receives: Drug: KH001; Drug: Placebo |
| Group C | Placebo comparator | Placebo 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 an evaporative air
Measured: Baseline and Week 5
Secondary outcomes (3)
Change from baseline in a Schiff sensitivity score
Schiff sensitivity score 0-3 by an evaporative air
Measured: Baseline, Up to 8 Weeks
Change from baseline in a Tactile threshold
Tactile threshold by yeaple probe
Measured: Baseline, Up to 8 Weeks
Change from baseline in Visual Analogue Scale
Visual Analogue Scale by an evaporative air
Measured: Baseline, Up to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start8 Oct 2024
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- HysensBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Forsyth Institute
- Responsible party
- Sponsor
- Investigators
- Hatice Hasturk, Principal investigator, ADA Forsyth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464939
- Sponsor's protocol ID
- KH-001-G201
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of Three Topical Applications of KH001 in Providing Long-term Relief From Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT06464939
- Acronym / sponsor ID
- KH-001-G201
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin Sensitivity, Denin Hypersensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- HysensBio Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- The Forsyth Institute
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 18 Jun 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 subjects with dentin hypersensitivity.
Detailed description
The study will consist of a screening period, a treatment period, and a follow-up period. The total duration of the study for each subject will be approximately 8 to 12 weeks. All subjects will be randomly assigned in a 1:1:1 ratio, with Group A, Group B and Group C.
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: KH001, Drug: PlaceboKH001 and placebo |
| Group B | Experimental | Drug: KH001, Drug: PlaceboKH001 and placebo |
| Group C | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least 18 years old by the time of the screening visit
- Is in good general health as determined by the investigator
- Has 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
- Is jedged 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 |
|---|---|---|
| KH001Application of KH001 over a 1 or 2-week period | Drug | Group A, Group B |
| PlaceboApplications of water for injection | Drug | Group A, Group B, Group C |
Primary outcome
Change from baseline in Schiff sensitivity score
Time frame: Baseline and Week 5
Schiff sensitivity score 0-3 by an evaporative air
3 secondary outcomes
Change from baseline in a Schiff sensitivity score
Time frame: Baseline, Up to 8 Weeks
Change from baseline in a Tactile threshold
Time frame: Baseline, Up to 8 Weeks
Change from baseline in Visual Analogue Scale
Time frame: Baseline, Up to 8 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 29 Oct 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.
Hatice Hasturk principal investigator
ADA Forsyth
2 sites 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 2 sites in United States.
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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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 29 Oct 2026.