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Completed

NCT Number: NCT06464939

Phase 2 Study of KH001 in 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.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ADA Forsyth, Cambridge, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KH001

Drug

Applications of KH001 over a 1 or 2-week period, and application of placebo

Placebo

Drug

Applications of water for injection

Primary outcomes

  1. Change from baseline in Schiff sensitivity score

    Time frame: Baseline and Week 5

    Schiff sensitivity score 0-3 by an evaporative air

Secondary outcomes

  1. Change from baseline in a Schiff sensitivity score

    Time frame: Baseline, Up to 8 Weeks

    Schiff sensitivity score 0-3 by an evaporative air

  2. Change from baseline in a Tactile threshold

    Time frame: Baseline, Up to 8 Weeks

    Tactile threshold by yeaple probe

  3. Change from baseline in Visual Analogue Scale

    Time frame: Baseline, Up to 8 Weeks

    Visual Analogue Scale by an evaporative air

Sponsors and collaborators

Lead sponsor

HysensBio Co., Ltd

Industry

Collaborators

  • The Forsyth Institute

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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