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NCT05768373

A Comparison Study of Hypersensitivity Treatment

Completed NA Results posted Last updated 7 February 2025
What this trial tests

NA trial testing 3M™ Clinpro™ Fluoride Aqueous Solution in Dentin Hypersensitivity in 101 participants. Completed in 14 July 2023.

Timeline
4 April 2023
Primary endpoint
14 July 2023
14 July 2023

Quick facts

Lead sponsorSolventum US LLC
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment101
Start date4 April 2023
Primary completion14 July 2023
Estimated completion14 July 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Solventum US LLC — full company profile →

Who can join

18 and older, any sex, with Dentin Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain From Baseline Immediately After Application of Test Product. Primary · Base line and immediately after application (within 15 minutes post-treatment).

Change in sensitivity as assessed using a Visual Analog Scale (VAS, 0 - 100 mm) immediately after exposure to air stimulus relative to baseline. The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.

GroupValue95% CI
3M™ Clinpro™ Fluoride Aqueous Solution8.9± 10.26
3M™ Vanish™8.6± 8.41
Change in Pain From Baseline 24 Hours Post Application of Test Product. Primary · Baseline and 24 hours post-treatment

This is a co-primary endpoint Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 24 hours after exposure to air stimulus relative to baseline. The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.

GroupValue95% CI
3M™ Clinpro™ Fluoride Aqueous Solution12.8± 10.57
3M™ Vanish™11.5± 9.43
Change in Pain From Baseline 7 Days Post Application of Test Product. Secondary · Baseline and 7 days post-treatment

Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 7 days after exposure to air stimulus relative to baseline. The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.

GroupValue95% CI
3M™ Clinpro™ Fluoride Aqueous Solution14.6± 13.45
3M™ Vanish™12.9± 11.45
Change in Pain From Baseline 21 Days Post Application of Test Product. Secondary · Baseline and 21 days post-treatment

Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 21 days after exposure to air stimulus relative to baseline. The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.

GroupValue95% CI
3M™ Clinpro™ Fluoride Aqueous Solution18.6± 13.69
3M™ Vanish™16.4± 12.47
Change in Pain From Baseline 30 Days Post Application of Test Product. Secondary · Baseline and 30 days post-treatment

Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 30 days after exposure to air stimulus relative to baseline. The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.

GroupValue95% CI
3M™ Clinpro™ Fluoride Aqueous Solution22.1± 16.81
3M™ Vanish™20.3± 15.05

Sponsor's own description

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™.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Dentin Hypersensitivity

Currently open trials in the same condition.

Other Solventum US LLC trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05768373.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing