A Comparison Study of Hypersensitivity Treatment
NCT05768373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2025-02-07
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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