A Comparison Study of Hypersensitivity Treatment

NCT05768373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-02-07

Study results available
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Summary

The goal of this clinical trial is to evaluate the effect of 3M™ Clinpro™ Fluoride Aqueous Solution (experimental) on Dentin Hypersensitivity (DHS) in comparison to 3M™ Vanish™ (commercialized, control\] in patients who have DHS.

Participants will be asked to complete the following activities:

Undergo a pre-treatment washout period for 3- to 6-weeks (± 4 days) post-enrollment. During this time, the Subject is to only use the provided oral hygiene products.

Hypersensitivity will be assessed prior to (baseline) and immediately after sample application.

Subject will be asked to come to the facility for hypersensitivity assessments at 24 hours, 7 days, and 30 days after the treatment visit.

Researchers will compare 3M™ Clinpro™ Fluoride Aqueous Solution to 3M™ Vanish™ to evaluate if the effect of Clinpro™ on DHS treatment is non-inferior to Vanish™.

Conditions

  • Dentin Hypersensitivity

Interventions

DEVICE

3M™ Clinpro™ Fluoride Aqueous Solution

Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.

DEVICE

3M™ Vanish™

Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.

Sponsors & Collaborators

  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Yiming Li · Loma Linda University, School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2023-07-14
Completion
2023-07-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05768373 on ClinicalTrials.gov