Dentin Hypersensitivity
Conditions
Brief 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.
Interventions
DEVICE3M™ Clinpro™ Fluoride Aqueous Solution
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
DEVICE3M™ Vanish™
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Sponsors
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only subject will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject has at least one affected hypersensitive tooth upon air blast stimuli in the cervical area, and baseline pain score of 40 mm and above as assessed by the 100 mm VAS. 2. Subject is at least 18 years old and have a minimum of 20 natural teeth. 3. Subject is willing to withhold desensitizing treatment, including prescription, in-office or over the counter (OTC) desensitizing products, throughout the study period AND withhold during the washout period. 4. Subject agrees to only use the provided toothpaste, toothbrush, and follows all oral hygiene instructions throughout the study period AND follows all oral hygiene instructions during the washout period. 5. Subject is able to understand and willing to sign the Informed Consent, and is willing to return to the study facility for scheduled study visits and recalls.
Exclusion criteria
1. Subject has medical (including psychiatric) and pharmacotherapeutic histories that may compromise the protocol - including the chronic use of anti-inflammatory, analgesic (pain), and mind-altering drugs; or analgesic (pain) medications within 48 hours prior to application of treatment. 2. Subject is pregnant (self-reported) or breast feeding. 3. Subject has allergies to product ingredients, eg, rosin, mint flavoring. 4. Subject has systemic conditions that are etiologic or predisposing to dentin hypersensitivity (eg, chronic acid regurgitation). 5. Subject has excessive dietary or environmental exposure to acids at time of screening. 6. Subject had periodontal treatment, bleaching treatments, or orthodontic treatments within previous 3 months or plans to have any other dental treatments during the study period. 7. Subject is enrolled in another clinical trial at the time of screening that would interfere with this study. 8. Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain From Baseline Immediately After Application of Test Product. | 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. |
| Change in Pain From Baseline 24 Hours Post Application of Test Product. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain From Baseline 7 Days Post Application of Test Product. | 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. |
| Change in Pain From Baseline 21 Days Post Application of Test Product. | 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. |
| Change in Pain From Baseline 30 Days Post Application of Test Product. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution Investigational product.
3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity. | 51 |
| 3M™ Vanish™ Commercialized product
3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity. | 50 |
| Total | 101 |
Baseline characteristics
| Characteristic | 3M™ Clinpro™ Fluoride Aqueous Solution | 3M™ Vanish™ | Total |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 12.38 | 44.6 years STANDARD_DEVIATION 14 | 44.2 years STANDARD_DEVIATION 13.15 |
| Air Blast VAS (Visual Analog Scale) baseline | 62.9 units on a scale STANDARD_DEVIATION 13.33 | 59.8 units on a scale STANDARD_DEVIATION 9.95 | 61.3 units on a scale STANDARD_DEVIATION 11.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 34 Participants | 34 Participants | 68 Participants |
| Region of Enrollment United States | 51 participants | 50 participants | 101 participants |
| Sex: Female, Male Female | 36 Participants | 29 Participants | 65 Participants |
| Sex: Female, Male Male | 15 Participants | 21 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 0 / 51 | 0 / 50 |
| serious Total, serious adverse events | 0 / 51 | 0 / 50 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | Change in Pain From Baseline 24 Hours Post Application of Test Product. | 12.8 units on a scale | Standard Deviation 10.57 |
| 3M™ Vanish™ | Change in Pain From Baseline 24 Hours Post Application of Test Product. | 11.5 units on a scale | Standard Deviation 9.43 |
95% CI: [-2.6, 5.3]
Primary
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | Change in Pain From Baseline Immediately After Application of Test Product. | 8.9 units on a scale | Standard Deviation 10.26 |
| 3M™ Vanish™ | Change in Pain From Baseline Immediately After Application of Test Product. | 8.6 units on a scale | Standard Deviation 8.41 |
95% CI: [-3.4, 4]
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | Change in Pain From Baseline 21 Days Post Application of Test Product. | 18.6 units on a scale | Standard Error 13.69 |
| 3M™ Vanish™ | Change in Pain From Baseline 21 Days Post Application of Test Product. | 16.4 units on a scale | Standard Error 12.47 |
95% CI: [-3, 7.4]
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | Change in Pain From Baseline 30 Days Post Application of Test Product. | 22.1 units on a scale | Standard Deviation 16.81 |
| 3M™ Vanish™ | Change in Pain From Baseline 30 Days Post Application of Test Product. | 20.3 units on a scale | Standard Deviation 15.05 |
95% CI: [-4.4, 8.2]
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | Change in Pain From Baseline 7 Days Post Application of Test Product. | 14.6 units on a scale | Standard Deviation 13.45 |
| 3M™ Vanish™ | Change in Pain From Baseline 7 Days Post Application of Test Product. | 12.9 units on a scale | Standard Deviation 11.45 |
95% CI: [-3.2, 6.7]