An interventional study of 3M™ Clinpro™ Fluoride Aqueous Solution and 3M™ Vanish™ in Dentin Hypersensitivity, sponsored by Solventum US LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Solventum US LLC · Not applicable, Interventional, and Treatment
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™.
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.
283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.
This study's enrollment of 101 is above the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →Solventum US LLC is the lead sponsor of 62 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.
Individual teeth may not be included that meet any of the following criteria:
Investigational product.
Device: 3M™ Clinpro™ Fluoride Aqueous Solution
Commercialized product
Device: 3M™ Vanish™
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Change in Pain From Baseline Immediately After Application of Test Product.
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.
Time frame: Base line and immediately after application (within 15 minutes post-treatment).
Change in Pain From Baseline 24 Hours Post Application of Test Product.
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.
Time frame: Baseline and 24 hours post-treatment
Change in Pain From Baseline 7 Days Post Application of Test Product.
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.
Time frame: Baseline and 7 days post-treatment
Change in Pain From Baseline 21 Days Post Application of Test Product.
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.
Time frame: Baseline and 21 days post-treatment
Change in Pain From Baseline 30 Days Post Application of Test Product.
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.
Time frame: Baseline and 30 days post-treatment
| Milestone | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ |
|---|---|---|
| Started | 51 | 50 |
| Completed | 51 | 50 |
| Not completed | 0 | 0 |
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.
| units on a scale | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ |
|---|---|---|
| Change in Pain From Baseline Immediately After Application of Test Product. | 8.9 ± 10.26 | 8.6 ± 8.41 |
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.
| units on a scale | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ |
|---|---|---|
| Change in Pain From Baseline 24 Hours Post Application of Test Product. | 12.8 ± 10.57 | 11.5 ± 9.43 |
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.
| units on a scale | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ |
|---|---|---|
| Change in Pain From Baseline 7 Days Post Application of Test Product. | 14.6 ± 13.45 | 12.9 ± 11.45 |
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.
| units on a scale | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ |
|---|---|---|
| Change in Pain From Baseline 21 Days Post Application of Test Product. | 18.6 ± 13.69 | 16.4 ± 12.47 |
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.
| units on a scale | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ |
|---|---|---|
| Change in Pain From Baseline 30 Days Post Application of Test Product. | 22.1 ± 16.81 | 20.3 ± 15.05 |
Collected over AEs will be collected from the time of initial application of control or investigational treatment until end of study visit (30 days post-application).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| 3M™ Vanish™ | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ | Total |
|---|---|---|---|
| Mean | 43.8 ± 12.38 | 44.6 ± 14.00 | 44.2 ± 13.15 |
| Sex: Female, Male(Participants) | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ | Total |
|---|---|---|---|
| Female | 36 | 29 | 65 |
| Male | 15 | 21 | 36 |
| Race (NIH/OMB)(Participants) | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 7 | 6 | 13 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Black or African American | 3 | 1 | 4 |
| White | 34 | 34 | 68 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 3 | 6 | 9 |
| Region of Enrollment(participants) | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ | Total |
|---|---|---|---|
| United States | 51 | 50 | 101 |
| Air Blast VAS (Visual Analog Scale) baseline(units on a scale) | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ | Total |
|---|---|---|---|
| Mean | 62.9 ± 13.33 | 59.8 ± 9.95 | 61.3 ± 11.82 |
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Solventum US LLC