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Trial Outcomes & Findings for The Efficacy of a Toothpaste to Reduce Sensitivity (NCT NCT00763269)

NCT ID: NCT00763269

Last Updated: 2012-03-07

Results Overview

Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

626 participants

Primary outcome timeframe

4 weeks

Results posted on

2012-03-07

Participant Flow

subjects were recruited by the PI at the clinical site

subjects were screened for medical and oral health criteria and then entered a 1 week washout before study treatment period.

Participant milestones

Participant milestones
Measure
A-Experimental Toothpatse
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
Fluoride/Triclosan control toothpaste
Overall Study
STARTED
314
312
Overall Study
COMPLETED
302
299
Overall Study
NOT COMPLETED
12
13

Reasons for withdrawal

Reasons for withdrawal
Measure
A-Experimental Toothpatse
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
Fluoride/Triclosan control toothpaste
Overall Study
Lost to Follow-up
12
13

Baseline Characteristics

The Efficacy of a Toothpaste to Reduce Sensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
A-Experimental Toothpatse
n=314 Participants
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
n=312 Participants
Fluoride/Triclosan control toothpaste
Total
n=626 Participants
Total of all reporting groups
Age, Categorical
<=18 years
7 Participants
n=5 Participants
2 Participants
n=7 Participants
9 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
301 Participants
n=5 Participants
306 Participants
n=7 Participants
607 Participants
n=5 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
4 Participants
n=7 Participants
10 Participants
n=5 Participants
Age Continuous
40.6 years
STANDARD_DEVIATION 13.4 • n=5 Participants
41.4 years
STANDARD_DEVIATION 12.1 • n=7 Participants
41 years
STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male
Female
226 Participants
n=5 Participants
233 Participants
n=7 Participants
459 Participants
n=5 Participants
Sex: Female, Male
Male
88 Participants
n=5 Participants
79 Participants
n=7 Participants
167 Participants
n=5 Participants
Region of Enrollment
United States
314 participants
n=5 Participants
312 participants
n=7 Participants
626 participants
n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth

Outcome measures

Outcome measures
Measure
A-Experimental Toothpatse
n=314 Participants
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
n=312 Participants
Fluoride/Triclosan control toothpaste
Hypersensitivity Tactile(Yeaple Probe)
19.81 units on a scale
Standard Deviation 9.56
13.94 units on a scale
Standard Deviation 6.42

PRIMARY outcome

Timeframe: 8 weeks

Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth

Outcome measures

Outcome measures
Measure
A-Experimental Toothpatse
n=314 Participants
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
n=312 Participants
Fluoride/Triclosan control toothpaste
Hypersensitivity Tactile (Yeaple Probe)
31.90 Units on a scale
Standard Deviation 12.26
17.28 Units on a scale
Standard Deviation 8.86

SECONDARY outcome

Timeframe: 4 weeks

Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.

Outcome measures

Outcome measures
Measure
A-Experimental Toothpatse
n=314 Participants
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
n=312 Participants
Fluoride/Triclosan control toothpaste
Air Blast Hypersensitivity (4 Week)
1.61 units on a scale
Standard Deviation 0.62
2.18 units on a scale
Standard Deviation 0.60

SECONDARY outcome

Timeframe: 8 weeks

Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.

Outcome measures

Outcome measures
Measure
A-Experimental Toothpatse
n=314 Participants
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
n=312 Participants
Fluoride/Triclosan control toothpaste
Air Blast Hypersensitivity (8 Week)
0.89 units on a scale
Standard Deviation 0.69
1.80 units on a scale
Standard Deviation 0.72

Adverse Events

A-Experimental Toothpatse

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

B -Control Toothpaste

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
A-Experimental Toothpatse
n=314 participants at risk
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
B -Control Toothpaste
n=312 participants at risk
Fluoride/Triclosan control toothpaste
General disorders
Burning sensation of mucosa
0.32%
1/314 • Number of events 1 • 8 weeks
0.32%
1/312 • Number of events 1 • 8 weeks
General disorders
Redness in Perioral area (possible allergic reaction)
0.32%
1/314 • Number of events 1 • 8 weeks
0.00%
0/312 • 8 weeks
General disorders
Physical Accidents w/ injuries
0.32%
1/314 • Number of events 1 • 8 weeks
0.96%
3/312 • Number of events 4 • 8 weeks

Additional Information

William De Vizio

Colgate Palmolive Co.

Phone: 732-878-7901

Results disclosure agreements

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

Restriction type: LTE60