KH001 for Tooth Sensitivity

Recruiting at 1 trial location

Overseen By Juyoung Ryu

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: HysensBio Co., Ltd

Disqualifiers: Allergies, Alcohol or drug abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KH001 to determine its effectiveness in reducing tooth sensitivity, also known as dentin hypersensitivity, and to ensure its safety. Participants will be divided into groups to receive either the KH001 treatment or a placebo (a substance with no active drug). The trial seeks individuals with at least two sensitive teeth that are not adjacent. If tooth sensitivity disrupts daily activities like eating or drinking cold foods, this trial might be suitable. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that KH001 is likely to be safe for humans?

Research has shown that potassium-based treatments, like KH001, are generally safe for treating tooth sensitivity. Similar treatments, such as potassium chloride and potassium nitrate, were well-tolerated in past studies. Although specific data on KH001's safety in humans remains limited, its progression to a Phase 2 trial indicates it passed initial safety tests. This suggests earlier studies likely found it safe, but further research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for tooth sensitivity, like desensitizing toothpaste or fluoride gels, work by blocking nerve signals or strengthening enamel. But KH001 works differently, targeting the root cause of sensitivity by repairing the tiny channels in teeth that lead to nerve endings. Researchers are excited about KH001 because of its potential to provide longer-lasting relief by addressing the underlying issue rather than just masking symptoms. Additionally, its unique mechanism could mean fewer applications and faster results compared to traditional treatments.

What evidence suggests that KH001 might be an effective treatment for tooth sensitivity?

Studies have shown that KH001 can significantly reduce pain in people with sensitive teeth. One study with 31 participants found that using gaseous ozone, a component of KH001, led to a 55% drop in pain immediately after treatment. KH001 provides pain relief by blocking the tiny channels in teeth that cause pain. This method is gaining interest because it offers quick relief from the sharp pain caused by exposed dentin, the sensitive part of a tooth. Overall, the initial research appears promising for those dealing with dentin hypersensitivity.

In this trial, researchers will assign participants to different groups, with some receiving KH001 and others receiving a placebo, to further evaluate its effectiveness. ^{2 3 6 7 8}

Who Is on the Research Team?

Hatice Hasturk

Principal Investigator

ADA Forsyth

Are You a Good Fit for This Trial?

This trial is for individuals experiencing tooth sensitivity due to hypersensitive dentin. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Is in good general health as determined by the investigator

I have sensitive teeth and at least 2 of them are not next to each other.

Exclusion Criteria

Has any history of alcohol or drug abuse

I have not received treatment for sensitive teeth in the last 8 weeks.

Is judged by the investigator as ineligible for participation for other reasons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three topical applications of KH001 or placebo

5 weeks

Weekly visits for treatment application

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KH001

Trial Overview The study is testing KH001's effectiveness in providing long-term relief from dentin hypersensitivity compared to a placebo. It's a Phase 2 trial, which means it focuses on efficacy and side effects.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 2 Interventions

KH001 and placebo

Group II: Group A Experimental Treatment 2 Interventions

KH001 and placebo

Group III: Group C Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

HysensBio Co., Ltd

Lead Sponsor

Trials

4

Recruited

340+

The Forsyth Institute

Collaborator

Trials

16

Recruited

1,900+

Published Research Related to This Trial

A systematic review of 8 trials involving 234 patients found that laser therapy for dentin hypersensitivity may offer a slight clinical advantage over topical desensitizing agents, although results were conflicting among studies.

The application of lasers was generally safe, with no reported adverse effects such as pulpal damage or allergic reactions, suggesting that laser treatment can be a viable option for managing tooth sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser therapy may be better than topical desensitizing agents for treating dentin hypersensitivity. Blatz, MB.[2012]

In a study involving 24 periodontal patients, the application of saturated potassium nitrate (KNO3) significantly reduced dentinal hypersensitivity, with a p-value of less than 0.0001 indicating strong statistical significance.

The treatment was assessed using a visual analogue scale, comparing pain levels before and after KNO3 application across 36 regions involving 98 teeth, demonstrating its efficacy in relieving pain associated with exposed dentin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypersensitive dentinal pain attenuation with potassium nitrate. Touyz, LZ., Stern, J.[2012]

Calcium hydroxide was found to be more effective than potassium nitrate and the control in reducing sensitivity of hypersensitive root surfaces, showing significant results immediately and after 3 months.

The study suggests that calcium hydroxide could be a useful desensitizing agent following periodontal surgery to help manage pain and facilitate better oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium hydroxide and potassium nitrate as desensitizing agents for hypersensitive root surfaces. Green, BL., Green, ML., McFall, WT.[2013]

In a study involving 48 subjects over eight weeks, a dentifrice containing 5.0% potassium nitrate significantly reduced dentinal hypersensitivity compared to a placebo, with improvements noted in both tactile and thermal sensitivity after just four weeks (p < 0.0001).

The effectiveness of the potassium nitrate dentifrice continued to show significant improvements at the eight-week mark, confirming its clinical efficacy in managing dentinal hypersensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a dentifrice containing 5% potassium nitrate and 1500 PPM sodium monofluorophosphate in a precipitated calcium carbonate base on dentinal hypersensitivity. Schiff, T., Dos Santos, M., Laffi, S., et al.[2013]

In a study involving 171 dentists and 1862 patients with dentinal hypersensitivity (DH), about 60% of patients reported a reduction in pain after receiving various treatments, indicating that community-based dental practices can effectively manage DH.

Patients who experienced pain relief from treatments such as glutaraldehyde/HEMA compounds, oxalates, and bonding agents also reported high satisfaction with their care, highlighting the importance of patient-centered outcomes in evaluating treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Dentinal Hypersensitivity Treatment Outcomes: Results from the National Dental PBRN. Heft, MW., Litaker, MS., Kopycka-Kedzierawski, DT., et al.[2019]

In a study involving 36 patients, both calcium hydroxide suspension and glutaraldehyde-based dentine primer effectively reduced tooth sensitivity after full crown preparation, with significant decreases in sensitivity observed over time.

No significant differences in efficacy were found between the two desensitizers, suggesting that both can be used interchangeably to manage sensitivity during dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of using calcium hydroxide or a dentine primer for reducing dentinal pain following crown preparation: a randomized clinical trial with an observation time up to 30 months. Wolfart, S., Wegner, SM., Kern, M.[2013]

The experimental dentifrice containing 3.75% potassium chloride (KCl) significantly reduced dentin hypersensitivity (DH) more effectively than the standard fluoride dentifrice over an eight-week period, as measured by the Schiff sensitivity score.

Both dentifrices were well tolerated, but the reference fluoride dentifrice showed a greater increase in tactile threshold after eight weeks, indicating some differences in how each product affects sensitivity, despite both being effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Study to Evaluate the Efficacy of an Experimental 3.75% (w/w) Potassium Chloride Dentifrice for the Relief of Dentin Hypersensitivity. Young, S., Wang, N., Mason, S., et al.[2018]

In a clinical study with 62 participants over 8 weeks, a dentifrice containing potassium chloride (KCl) significantly reduced dentin hypersensitivity compared to a placebo, showing effectiveness as early as 4 weeks.

The combination of KCl with sodium monofluorphosphate (MFP) was also effective, and both formulations led to significant improvements in patient comfort and reduced plaque levels by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Desensitizing effect of a potassium chloride dentifrice. Silverman, G., Gingold, J., Curro, FA.[2013]

In a study of 45 patients with dentinal hypersensitivity, both low-level laser therapy (LLLT) alone and LLLT combined with 5% potassium nitrate (KNO3) toothpaste significantly reduced sensitivity more effectively than using KNO3 toothpaste alone over a 3-week period.

The results indicated that LLLT alone provided better relief from hypersensitivity after just one week compared to the combination treatment, suggesting that using toothpaste with LLLT does not offer additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of dentinal hypersensitivity using low-level laser therapy and 5% potassium nitrate: A randomized, controlled, three arm parallel clinical study. Pandey, R., Koppolu, P., Kalakonda, B., et al.[2020]

Treatment with gaseous ozone significantly reduced pain in hypersensitive teeth by 55% immediately after application, based on a study involving 31 subjects over 54 weeks.

While the pain levels decreased significantly in both the treated and control teeth over time, there was no significant difference in pain reduction between the test and control teeth, suggesting that the long-term benefits of ozone treatment may not be superior to natural healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating sensitive cervical areas with ozone. A prospective controlled clinical trial. Dähnhardt, JE., Gygax, M., Martignoni, B., et al.[2013]

In a 12-week study involving 41 subjects, the dentifrice containing potassium chloride and sodium monofluorophosphate significantly reduced dentinal hypersensitivity compared to a placebo, with noticeable effects within just 4 weeks.

The KCl/MFP dentifrice not only alleviated sensitivity but also led to significant plaque reduction by week 8, indicating additional oral health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of a dentifrice containing potassium chloride as a desensitizing agent. Salvato, AR., Clark, GE., Gingold, J., et al.[2013]

A clinical trial involving 67 subjects demonstrated that toothpaste containing 5.53% potassium citrate significantly reduced dentine hypersensitivity compared to a control toothpaste over an 8-week period.

The test group using potassium citrate toothpaste reported a greater reduction in sensitivity to cold air and overall self-perceived sensitivity than the control group, with statistically significant results at both 4 and 8 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical study on the effectiveness of desensitizing toothpaste in patients with dentine hypersensitivity]. Liang, Y., Rong, Ws., Wang, Wj., et al.[2017]

In a 4-week study involving 27 subjects, potassium nitrate (5%) in a low abrasive toothpaste significantly reduced dentinal hypersensitivity, with noticeable effects starting within just one week.

The treatment was effective in desensitizing hypersensitive teeth without affecting normally sensitive teeth or causing any adverse effects on oral tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new treatment for dentinal hypersensitivity. Tarbet, WJ., Silverman, G., Stolman, JM., et al.[2015]

The novel varnish containing potassium chloride and fluoridated hydroxyapatite effectively occluded dentinal tubules and significantly reduced dentin permeability compared to commercial fluoride varnish, making it a promising treatment for dentin hypersensitivity.

The varnish demonstrated biocompatibility with gingival and pulpal fibroblasts, indicating it is safe for use in dental applications without causing cytotoxic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The synthesis and characterization of a novel potassium chloride-fluoridated hydroxyapatite varnish for treating dentin hypersensitivity. Lochaiwatana, Y., Poolthong, S., Hirata, I., et al.[2016]

A randomized controlled trial with 63 participants showed that a dentifrice containing 5% potassium nitrate significantly reduced dental hypersensitivity over a 4-week period, as measured by a pain scale.

After 4 weeks, the potassium nitrate dentifrice group reported a greater reduction in pain compared to the fluoride dentifrice group, indicating its superior efficacy for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of a dentifrice containing 5% potassium nitrate on dental hypersensitivity]. Zhuang, WJ., Cao, D.[2018]

Citations

1. withpower.com withpower.com/trial/phase-2-hypersensitivity-7-2024-97386

KH001 for Tooth Sensitivity Treatment with gaseous ozone significantly reduced pain in hypersensitive teeth by 55% immediately after application, based on a study involving 31 subjects ...

2. clinconnect.io clinconnect.io/trials/NCT06264453

A Study to Evaluate the Efficacy and Safety of KH001 in The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.

3. malacards.org malacards.org/card/dentin_sensitivity

Dentin Sensitivity Integrated disease information for Dentin Sensitivity including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 data ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12361636/

First‐In‐Human Study of Safety, Tolerability, Efficacy, and ... ABSTRACT. Dentin hypersensitivity is characterized by transient, sharp pain resulting from dentin exposure due to enamel or cementum loss.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Hypersensitivity%20Dentin%22

San Mateo Clinical Trials The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity. Effectiveness of Bioactiveglass Air ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06464939

Phase 2 Study of KH001 in Long-term Relief from Dentin ... Study Overview. Brief Summary. The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.

7. ctv.veeva.com ctv.veeva.com/study/phase-2-clinical-trial-to-evaluate-the-efficacy-and-safety-of-kh001-in-patients-with-dentin-hypersen

A Study to Evaluate the Efficacy and Safety of KH001 in ... The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0046413

Dentine Hypersensitivity (DBCOND0046413) A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity. KH001. treatment, 2, completed. NCT06276777. The Effect of Using ...