NCT06464939

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 8, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

June 13, 2024

Last Update Submit

January 11, 2026

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 an evaporative air

    Baseline and Week 5

Secondary Outcomes (3)

  • Change from baseline in a Schiff sensitivity score

    Baseline, Up to 8 Weeks

  • Change from baseline in a Tactile threshold

    Baseline, Up to 8 Weeks

  • Change from baseline in Visual Analogue Scale

    Baseline, Up to 8 Weeks

Study Arms (3)

Group A

EXPERIMENTAL

KH001 and placebo

Drug: KH001Drug: Placebo

Group B

EXPERIMENTAL

KH001 and placebo

Drug: KH001Drug: Placebo

Group C

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

KH001DRUG

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

Group AGroup B
PlaceboDRUG

Applications of water for injection

Group AGroup BGroup C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • Is jedged by the investigator as ineligible for participation for other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ADA Forsyth

Cambridge, Massachusetts, 02142, United States

Location

Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Hatice Hasturk

    ADA Forsyth

    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

June 13, 2024

First Posted

June 18, 2024

Study Start

October 8, 2024

Primary Completion

December 22, 2025

Study Completion

December 22, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)