NCT05768373

A Comparison Study of Hypersensitivity Treatment

Clinical Evaluation of Clinpro™ 2.1% Sodium Fluoride Aqueous Solution in the Treatment of Dentin Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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™.

Detailed description

After Informed Consent has been obtained, the subjects will be given study supplied oral hygiene products (e.g., toothbrush and toothpaste) to be used immediately after the consent visit and throughout the entire duration of the study. Subjects will have a minimum wash-out period of 3 weeks followed by 1 treatment visit. At the treatment visit, a pain assessment will be performed (ie, a baseline pain score) in response to both an air-blast stimulus and tactile stimulus. After each stimulus, the Subject should score their pain using a Visual Analog Scale (VAS). After recording baseline pain scores, Clinpro™ (Treatment arm) or Vanish™ (Control arm) will be applied according to the manufacturer's IFU. Pain in response to air blast and probe test will be assessed using VAS immediately after application of fluoride treatment (within 15 minutes). Pain response will be assessed again at 24 h, 7 d, 21 d and 30 d post-application of the treatment.

Conditions

• Dentin Hypersensitivity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-04
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2023-03-14
• Last updated: 2025-02-07
• Results posted: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study