NCT06264453

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

February 9, 2024

Last Update Submit

March 13, 2025

Conditions

Dentin Hypersensitivity

Keywords

Dentin SensitivityDenin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Schiff sensitivity score

    Schiff sensitivity score 0-3 by air blast

    Baseline and Day 36

Secondary Outcomes (3)

  • Change from baseline in a Schiff sensitivity score

    Baseline, Day 8, 15, 22 and 43

  • Change from baseline in a Tactile threshold

    Baseline, Day 8, 15, 22, 36 and 43

  • Change from baseline in Visual Analogue Scale

    Baseline, Day 8, 15, 22, 36 and 43

Study Arms (3)

Group A

EXPERIMENTAL

KH001 0.2mg/mL

Drug: KH001

Group B

EXPERIMENTAL

KH001 0.4mg/mL

Drug: KH001

Group C

PLACEBO COMPARATOR

Water for Injection

Drug: Placebo

Interventions

KH001DRUG

topical applications of KH001

Group AGroup B
PlaceboDRUG

topical applications of Water for Injection

Group C

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Dental Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Kyoung-Kyu Choi, D.D.S

    Kyung Hee University Dentistry Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 20, 2024

Study Start

March 19, 2024

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)