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Completed

NCT Number: NCT06264453

A Study 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.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyung Hee University Dental Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

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
  • Has active dental caries or history of dental caries

Treatment and study plan

KH001

Drug

topical applications of KH001

Placebo

Drug

topical applications of Water for Injection

Primary outcomes

  1. Change from baseline in Schiff sensitivity score

    Time frame: Baseline and Day 36

    Schiff sensitivity score 0-3 by air blast

Secondary outcomes

  1. Change from baseline in a Schiff sensitivity score

    Time frame: Baseline, Day 8, 15, 22 and 43

    Schiff sensitivity score 0-3 by an evaporative air

  2. Change from baseline in a Tactile threshold

    Time frame: Baseline, Day 8, 15, 22, 36 and 43

    Tactile threshold by yeaple probe

  3. Change from baseline in Visual Analogue Scale

    Time frame: Baseline, Day 8, 15, 22, 36 and 43

    100mm Visual Analogue Scale

Sponsors and collaborators

Lead sponsor

HysensBio Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Mar 14, 2025

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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