Evaluating KH001 for long-term relief from tooth sensitivity
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
This study is testing if a new treatment called KH001 can help people with sensitive teeth feel better for a longer time.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HysensBio Co., Ltd Industry-sponsored |
| Locations | 2 sites (Cambridge, Massachusetts and 1 other locations) |
| Trial ID | NCT06464939 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of KH001 in individuals suffering from dentin hypersensitivity. Participants will undergo a screening period followed by a treatment phase where they will be randomly assigned to receive either KH001 or a placebo. The total duration of the study for each participant will be approximately 8 to 12 weeks, including a follow-up period to monitor outcomes. The study will help determine if KH001 can provide long-term relief from the discomfort associated with sensitive teeth.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are in good health and have been diagnosed with dentin hypersensitivity.
Not a fit: Patients with allergies to the study drug or those who have recently received treatment for dentin hypersensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce tooth sensitivity and improve the quality of life for affected patients.
How similar studies have performed: Previous studies have shown promise in treating dentin hypersensitivity, but the specific approach with KH001 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Cambridge, Massachusetts and 1 other locations
- ADA Forsyth — Cambridge, Massachusetts, United States (Not_yet_recruiting)
- Forsyth Institute — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Hatice Hasturk — ADA Forsyth
- Study coordinator: Sunhee Park
- Email: sunheepark@hysensbio.com
- Phone: +82-2-502-6700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.