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Trial Outcomes & Findings for A Comparison Study of Hypersensitivity Treatment (NCT NCT05768373)

NCT ID: NCT05768373

Last Updated: 2025-02-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

Base line and immediately after application (within 15 minutes post-treatment).

Results posted on

2025-02-07

Participant Flow

Participant milestones

Participant milestones
Measure
3M™ Clinpro™ Fluoride Aqueous Solution
Investigational product. 3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™
Commercialized product 3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Overall Study
STARTED
51
50
Overall Study
COMPLETED
51
50
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison Study of Hypersensitivity Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
3M™ Clinpro™ Fluoride Aqueous Solution
n=51 Participants
Investigational product. 3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™
n=50 Participants
Commercialized product 3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Total
n=101 Participants
Total of all reporting groups
Age, Continuous
43.8 years
STANDARD_DEVIATION 12.38 • n=5 Participants
44.6 years
STANDARD_DEVIATION 14.00 • n=7 Participants
44.2 years
STANDARD_DEVIATION 13.15 • n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
29 Participants
n=7 Participants
65 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
21 Participants
n=7 Participants
36 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
7 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
White
34 Participants
n=5 Participants
34 Participants
n=7 Participants
68 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
6 Participants
n=7 Participants
9 Participants
n=5 Participants
Region of Enrollment
United States
51 participants
n=5 Participants
50 participants
n=7 Participants
101 participants
n=5 Participants
Air Blast VAS (Visual Analog Scale) baseline
62.9 units on a scale
STANDARD_DEVIATION 13.33 • n=5 Participants
59.8 units on a scale
STANDARD_DEVIATION 9.95 • n=7 Participants
61.3 units on a scale
STANDARD_DEVIATION 11.82 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
3M™ Clinpro™ Fluoride Aqueous Solution
n=51 Participants
Investigational product. 3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™
n=50 Participants
Commercialized product 3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Change in Pain From Baseline Immediately After Application of Test Product.
8.9 units on a scale
Standard Deviation 10.26
8.6 units on a scale
Standard Deviation 8.41

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
3M™ Clinpro™ Fluoride Aqueous Solution
n=51 Participants
Investigational product. 3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™
n=50 Participants
Commercialized product 3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Change in Pain From Baseline 24 Hours Post Application of Test Product.
12.8 units on a scale
Standard Deviation 10.57
11.5 units on a scale
Standard Deviation 9.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
3M™ Clinpro™ Fluoride Aqueous Solution
n=51 Participants
Investigational product. 3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™
n=50 Participants
Commercialized product 3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Change in Pain From Baseline 7 Days Post Application of Test Product.
14.6 units on a scale
Standard Deviation 13.45
12.9 units on a scale
Standard Deviation 11.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
3M™ Clinpro™ Fluoride Aqueous Solution
n=51 Participants
Investigational product. 3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™
n=50 Participants
Commercialized product 3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Change in Pain From Baseline 21 Days Post Application of Test Product.
18.6 units on a scale
Standard Error 13.69
16.4 units on a scale
Standard Error 12.47

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
3M™ Clinpro™ Fluoride Aqueous Solution
n=51 Participants
Investigational product. 3M™ Clinpro™ Fluoride Aqueous Solution: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™
n=50 Participants
Commercialized product 3M™ Vanish™: Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
Change in Pain From Baseline 30 Days Post Application of Test Product.
22.1 units on a scale
Standard Deviation 16.81
20.3 units on a scale
Standard Deviation 15.05

Adverse Events

3M™ Clinpro™ Fluoride Aqueous Solution

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

3M™ Vanish™

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Helen Han

Solventum

Phone: 6517856568

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place